Device, system, and method for transcatheter treatment of valvular regurgitation

ABSTRACT

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S.application Ser. No. 17/685,913 filed Mar. 3, 2022, which is acontinuation application of U.S. application Ser. No. 16/685,338 filedNov. 15, 2019, which is a continuation application of U.S. applicationSer. No. 16/275,665 filed Feb. 14, 2019, which is a continuation-in-partapplication of U.S. application Ser. No. 16/129,194 filed Sep. 12, 2018,which is a continuation-in-part application of U.S. application Ser. No.15/918,988 filed Mar. 12, 2018, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 62/470,684, filed on Mar. 13,2017. Each of the foregoing applications of which are herebyincorporated by reference in their entireties. Any and all applicationsfor which a foreign or domestic priority claim is identified in theApplication Data Sheet as filed with the present application, are herebyincorporated by reference in their entirety under 37 CFR 1.57.

BACKGROUND Field

The present disclosure generally provides improved medical devices,systems, and methods, typically for treatment of heart valve diseaseand/or for altering characteristics of one or more valves of the body.Embodiments include implants for treatment of mitral valveregurgitation.

The human heart receives blood from the organs and tissues via theveins, pumps that blood through the lungs where the blood becomesenriched with oxygen, and propels the oxygenated blood out of the heartto the arteries so that the organ systems of the body can extract theoxygen for proper function. Deoxygenated blood flows back to the heartwhere it is once again pumped to the lungs.

The heart includes four chambers: the right atrium (RA), the rightventricle (RV), the left atrium (LA) and the left ventricle (LV). Thepumping action of the left and right sides of the heart occurs generallyin synchrony during the overall cardiac cycle.

The heart has four valves generally configured to selectively transmitblood flow in the correct direction during the cardiac cycle. The valvesthat separate the atria from the ventricles are referred to as theatrioventricular (or AV) valves. The AV valve between the left atriumand the left ventricle is the mitral valve. The AV valve between theright atrium and the right ventricle is the tricuspid valve. Thepulmonary valve directs blood flow to the pulmonary artery and thence tothe lungs; blood returns to the left atrium via the pulmonary veins. Theaortic valve directs flow through the aorta and thence to the periphery.There are normally no direct connections between the ventricles orbetween the atria.

The mechanical heartbeat is triggered by an electrical impulse, whichspreads throughout the cardiac tissue. Opening and closing of heartvalves may occur primarily as a result of pressure differences betweenchambers, those pressures resulting from either passive filling orchamber contraction. For example, the opening and closing of the mitralvalve may occur as a result of the pressure differences between the leftatrium and the left ventricle.

At the beginning of ventricular filling (diastole) the aortic andpulmonary valves are closed to prevent back flow from the arteries intothe ventricles. Shortly thereafter, the AV valves open to allowunimpeded flow from the atria into the corresponding ventricles. Shortlyafter ventricular systole (i.e., ventricular emptying) begins, thetricuspid and mitral valves normally shut, forming a seal, whichprevents flow from the ventricles back into the corresponding atria.

Unfortunately, the AV valves may become damaged or may otherwise fail tofunction properly, resulting in improper closing. The AV valves arecomplex structures that generally include an annulus, leaflets, chordaeand a support structure. Each atrium interfaces with its valve via anatrial vestibule. The mitral valve has two leaflets; the analogousstructure of the tricuspid valve has three leaflets, and apposition orengagement of corresponding surfaces of leaflets against each otherhelps provide closure or sealing of the valve to prevent blood flowingin the wrong direction. Failure of the leaflets to seal duringventricular systole is known as malcoaptation, and may allow blood toflow backward through the valve (regurgitation). Heart valveregurgitation can have serious consequences to a patient, oftenresulting in cardiac failure, decreased blood flow, lower bloodpressure, and/or a diminished flow of oxygen to the tissues of the body.Mitral regurgitation can also cause blood to flow back from the leftatrium to the pulmonary veins, causing congestion. Severe valvularregurgitation, if untreated, can result in permanent disability ordeath.

Description of the Related Art

A variety of therapies have been applied for treatment of mitral valveregurgitation, and still other therapies may have been proposed but notyet actually used to treat patients. While several of the knowntherapies have been found to provide benefits for at least somepatients, still further options would be desirable. For example,pharmacologic agents (such as diuretics and vasodilators) can be usedwith patients having mild mitral valve regurgitation to help reduce theamount of blood flowing back into the left atrium. However, medicationscan suffer from lack of patient compliance. A significant number ofpatients may occasionally (or even regularly) fail to take medications,despite the potential seriousness of chronic and/or progressivelydeteriorating mitral valve regurgitation. Pharmacological therapies ofmitral valve regurgitation may also be inconvenient, are oftenineffective (especially as the condition worsens), and can be associatedwith significant side effects (such as low blood pressure).

A variety of surgical options have also been proposed and/or employedfor treatment of mitral valve regurgitation. For example, open-heartsurgery can replace or repair a dysfunctional mitral valve. Inannuloplasty ring repair, the posterior mitral annulus can be reduced insize along its circumference, optionally using sutures passed through amechanical surgical annuloplasty sewing ring to provide coaptation. Opensurgery might also seek to reshape the leaflets and/or otherwise modifythe support structure. Regardless, open mitral valve surgery isgenerally a very invasive treatment carried out with the patient undergeneral anesthesia while on a heart-lung machine and with the chest cutopen. Complications can be common, and in light of the morbidity (andpotentially mortality) of open-heart surgery, the timing becomes achallenge—sicker patients may be in greater need of the surgery, butless able to withstand the surgery. Successful open mitral valvesurgical outcomes can also be quite dependent on surgical skill andexperience.

Given the morbidity and mortality of open-heart surgery, innovators havesought less invasive surgical therapies. Procedures that are done withrobots or through endoscopes are often still quite invasive, and canalso be time consuming, expensive, and in at least some cases, quitedependent on the operator's skill. Imposing even less trauma on thesesometimes frail patients would be desirable, as would be providingtherapies that could be successfully implemented by a significant numberof physicians using widely distributed skills. Toward that end, a numberof purportedly less invasive technologies and approaches have beenproposed. These include devices which seek to re-shape the mitralannulus from within the coronary sinus; devices that attempt to reshapethe annulus by cinching either above to below the native annulus;devices to fuse the leaflets (imitating the Alfieri stitch); devices tore-shape the left ventricle, and the like.

Perhaps most widely known, a variety of mitral valve replacementimplants have been developed, with these implants generally replacing(or displacing) the native leaflets and relying on surgically implantedstructures to control the blood flow paths between the chambers of theheart. While these various approaches and tools have met with differinglevels of acceptance, none has yet gained widespread recognition as anideal therapy for most or all patients suffering from mitral valveregurgitation.

Because of the challenges and disadvantages of known minimally invasivemitral valve regurgitation therapies and implants, still furtheralternative treatments have been proposed. Some of the alternativeproposals have called for an implanted structure to remain within thevalve annulus throughout the heart beat cycle. One group of theseproposals includes a cylindrical balloon or the like to remain implantedon a tether or rigid rod extending between the atrium and the ventriclethrough the valve opening. Another group relies on an arcuate ringstructure or the like, often in combination with a buttress orstructural cross-member extending across the valve so as to anchor theimplant. Unfortunately, sealing between the native leaflets and the fullperimeter of a balloon or other coaxial body may prove challenging,while the significant contraction around the native valve annulus duringeach heart beat may result in significant fatigue failure issues duringlong-term implantation if a buttress or anchor interconnecting crossmember is allowed to flex. Moreover, the significant movement of thetissues of the valve may make accurate positioning of the implantchallenging regardless of whether the implant is rigid or flexible.

In light of the above, it would be desirable to provide improved medicaldevices, systems, and methods. It would be particularly desirable toprovide new techniques for treatment of mitral valve regurgitation andother heart valve diseases, and/or for altering characteristics of oneor more of the other valves of the body. The need remains for a devicewhich can directly enhance leaflet coaptation (rather than indirectlyvia annular or ventricular re-shaping) and which does not disruptleaflet anatomy via fusion or otherwise, but which can be deployedsimply and reliably, and without excessive cost or surgical time. Itwould be particularly beneficial if these new techniques could beimplemented using a less-invasive approach, without stopping the heartor relying on a heart-lung machine for deployment, and without relyingon exceptional skills of the operator to provide improved valve and/orheart function.

SUMMARY

The disclosure generally provides improved medical devices, systems, andmethods. New coaptation assistance elements, systems, and methods fortreatment of mitral valve regurgitation and other valve diseases aredisclosed. The coaptation assistance element may remain within the bloodflow path as the valve moves back and forth between an open-valveconfiguration and a closed valve configuration. The coaptationassistance elements may be relatively thin, elongate (along the bloodflow path), and/or conformable structures which extend laterally acrosssome, most, or all of the width of the valve opening, allowingcoaptation between at least one of the native leaflets and thecoaptation assistance element. The devices described herein can be usedwith any valve of the human body, including valves with two leaflets orthree leaflets.

In some embodiments, an advantage is the ability to retrieve thecoaptation assistance element. In some embodiments, the coaptationassistance element has a single anchor, which can engage or disengagetissue. In some embodiments, the anchor is captive within an annular hubof the coaptation assistance element. In some embodiments, the captiveanchor is removed simultaneously with the removal of the coaptationassistance element. In some embodiments, the coaptation assistanceelement can include secondary anchors. In some embodiments, thecoaptation assistance element can include passive anchors. In someembodiments, engagement of the anchor with the tissue positions one ormore passive anchors into engagement with tissue. In some embodiments,an advantage is to retrieve the coaptation assistance element during aprocedure. In some embodiments, the coaptation assistance element can berepositioned during a surgical procedure. In some embodiments, thecoaptation assistance element can be removed from the patient during asubsequent surgical procedure. In some embodiments, the coaptationassistance element can be replaced by another device during a subsequentsurgical procedure. In some embodiments, a single annular anchorfacilitates the ability to retrieve the coaptation assistance element.In some embodiments, the location of the annular anchor facilitates theability to retrieve the coaptation assistance element. In someembodiments, the ability to collapse the coaptation assistance elementwith the purse-string suture as described herein facilitates the abilityto retrieve the coaptation assistance element.

In some embodiments, an advantage is the connection between thecoaptation assistance element and the delivery catheter. In someembodiments, the coaptation assistance element includes an annular hubwith features to engage the delivery catheter. In some embodiments, thecoaptation assistance element and the delivery catheter are removablycoupled such that the coaptation assistance element can be released fromthe delivery catheter during a procedure. In some embodiments, one ormore secondary structures couples the coaptation assistance element andthe delivery catheter after the coaptation assistance element isreleased from the delivery catheter. In some embodiments, the one ormore secondary structures include the purse-string suture as descriedherein. In some embodiments, the one or more secondary structuresfacilitate the collapse and/or expansion of the coaptation assistanceelement. In some embodiments, the coaptation assistance element and thedelivery catheter are rotationally fixed relative to each other whencoupled. In some embodiments, relative motion of the delivery cathetercauses motion of the coaptation assistance element.

In some embodiments, an advantage is the coaptation assistance elementcan be delivered with a hub-leading orientation. In some methods of use,the annular hub can be moved into position relative to the anatomicalstructures. In some methods of use, the ventricular end of thecoaptation assistance element can be retained within the deliverycatheter until the annular hub is positioned. In some methods of use,once the annular hub and/or the annular anchor are engaged with thetissue, the coaptation assistance element can be expanded. In somemethods of use, once the annular hub and/or the annular anchor areengaged with the tissue, the ventricular end of the coaptationassistance element can be positioned.

In some embodiments, an advantage is the coaptation assistance elementcan be delivered with a strut-leading orientation. In this method ofuse, one or more of the struts of the coaptation assistance element canbe moved into position relative to the anatomical structures prior tothe positioning of the annular hub. In some methods of use, thecoaptation assistance element can be expanded or partially expandedprior to the engagement of the annular anchor. In some methods of use,the annular hub can be retained within the delivery catheter until oneor more of the struts are positioned. In some methods of use, once thestruts are positioned, the annular anchor can be engaged with thetissue.

In some embodiments, an advantage is the annular anchor can be rotatedindependently of the coaptation assistance element. As described herein,the coaptation assistance element is coupled to one portion of thedelivery catheter. As described herein, the annular anchor isindependently coupled to another portion of the delivery catheter, suchas a driver disposed with the delivery catheter. The annular anchor canbe rotated independently of the annular hub. The annular hub can remainstationary as the annular anchor is rotated to engage tissue. Theannular anchor can be driven into the tissue while the delivery catheterretains the position of the annular hub.

In some embodiments, an advantage is the ability to collapse thecoaptation assistance element. In some embodiments, the coaptationassistance element is fully collapsed. The fully collapsed configurationcan be the insertion configuration or a low profile configuration. Insome embodiments, the coaptation assistance element is partiallycollapsed. The partially collapsed configuration can be a partiallydeployed configuration. The partially collapsed configuration can allowthe coaptation assistance element to be selectively deployed within theheart. The partially collapsed configuration can allow the coaptationassistance element to be moved into position within the heart. Theconfigurations of the coaptation assistance element can be monitoredsuch as by imaging to ensure proper deployment. In some embodiments, oneor more purse-string sutures, or portions thereof, are tensioned tocollapse or partially collapse the coaptation assistance element. Insome embodiments, the partially collapsed configuration can allowrotation of the coaptation assistance element. In some embodiments, thefully collapsed configuration can allow rotation of the coaptationassistance element. In some embodiments, the coaptation assistanceelement can be rotated with a delivery catheter or portion thereof. Insome embodiments, the coaptation assistance element can be rotated abouta central location such as the annular hub.

In some embodiments, an advantage is the ability to expand thecoaptation assistance element. In some embodiments, one or morepurse-string sutures, or portions thereof, are released to expand thecoaptation assistance element. In some embodiments, release of thepurse-string suture allows one or more struts to assume a neutralconfiguration. In some embodiments, the release of the purse-stringsuture allows one or more struts to assume a pre-shaped curve. In someembodiments, the one or more struts comprise NiTi. In some embodiments,the purse-string suture can be repeatedly tensioned and/or released. Insome embodiments, the purse-string suture is captive within thecoaptation assistance element. In some embodiments, the purse-stringsuture is tensioned to remove the coaptation assistance element from apatient. In some embodiments, the purse-string suture is released todeploy the coaptation assistance element within the heart of a patient.In some embodiments, the purse-string suture can be selective deployedto expand a portion of coaptation assistance element while anotherportion of the coaptation assistance element remains collapsed orpartially collapsed.

In some embodiments, an advantage is the ability to adjust thecoaptation assistance element. In some embodiments, the coaptationassistance element can be held by a central location. In someembodiments, the central location is the anchor. In some embodiments,the central location is the hub. In some embodiments, the hub and/or theanchor are located generally near a mid-point of the diameter of thecoaptation assistance element. In some embodiments, the hub and/or theanchor are generally located near a mid-point and/or central location ofthe annular portion of the coaptation assistance element. In someembodiments, the coaptation assistance element can be held at a neutralposition. In some embodiments, the coaptation assistance element can berotated by rotating a delivery catheter connected to the annular hub. Insome embodiments, the coaptation assistance element can be movedlongitudinally by corresponding longitudinal motion of a deliverycatheter connected to the annular hub.

In some embodiments, an advantage is the coaptation assistance elementcan be retained by a delivery catheter after the coaptation assistanceelement is positioned. In some embodiments, the coaptation assistanceelement can be fully deployed within the mitral valve but still tetheredto a delivery catheter. In some embodiments, the coaptation assistanceelement can be adjusted after the coaptation assistance element is fullydeployed within the mitral valve. In some embodiments, the coaptationassistance element can be rotated about the hub after the coaptationassistance element is fully deployed. In some embodiments, the anchorcan be disengaged and/or reengaged with the tissue after the coaptationassistance element is fully deployed. In some embodiments, thepurse-string sutures can collapse and/or expand the coaptationassistance element or a portion thereof after the coaptation assistanceelement is fully deployed. In some embodiments, the coaptationassistance element can be recaptured after the coaptation assistanceelement is fully deployed. In some embodiments, the coaptationassistance element can be removed after the coaptation assistanceelement is fully deployed.

In some embodiments, an advantage is the coaptation assistance elementdoes not require ventricular attachment. In some embodiments, thecoaptation assistance element only requires annular attachment. In someembodiments, the coaptation assistance element only requires attachmentof an annular anchor through an annular hub. In some embodiments, thecoaptation assistance element only requires attachment of an annularanchor through an annular hub and annular barbs. In some embodiments,the coaptation assistance element only requires attachment of an annularanchor through an annular hub, annular barbs, and/or commissural barbs.

In some embodiments, an advantage is the radially extending frame. Insome embodiments, the frame comprises an annular hub and one or morestruts. In some embodiments, the struts extend radially from the annularhub. In some embodiments, the frame is constructed from a single, planarsheet of material. In some embodiments, the frame is precisely cut usingwater jet, laser etching or similar technology. In some embodiments, theframe is constructed by forming the annular hub with an edge of theframe. In some embodiments, the planar sheet of material is formed intoa loop which becomes the annular hub. In some embodiments, the strutsare bent to the desired configuration. In some embodiments, the strutsare equally spaced about the circumference of the annular hub. In someembodiments, the struts are unequally spaced about the circumference ofthe annular hub. In some embodiments, the struts extending along aportion of the circumference of the annular hub are different thanstruts extending along another portion of the circumference of theannular hub. In some embodiments, one or more designated portions of thestruts are designed to be placed near the annular region of the heart.In some embodiments, one or more designated portions of the struts aredesigned to be placed near the commissure region of the heart. In someembodiments, one or more designated portions of the struts are designedto be placed near the ventricular region of the heart. In someembodiments, the struts of the radially outward frame do not intersect.In some embodiments, the struts of the radially outward frame do notform a mesh. In some embodiments, the struts of the radially outwardframe extend in a line from the hub to an edge of the coaptationassistance element. In some embodiments, the struts of the radiallyoutward frame have a sharpened edge. In some embodiments, the sharpenededge extends in a straight line from the edge of the coaptationassistance element. In some embodiments, the sharpened edge isintegrally formed in the strut. In some embodiments, a strut of theradially outward frame has one or more radii of curvature. In someembodiments, a strut of the radially outward frame can be concave orconvex or both concave and convex along the length of the strut. In someembodiments, a strut of the radially outward frame has one or moreinflection points.

In some embodiments, an advantage is the curvature of the frame. In someembodiments, the annular hub is radially extending. In some embodiments,the annular hub extends from the coaptation assistance element away fromthe annulus. In some embodiments, the annular hub extends from a surfaceof the coaptation assistance element above a planar surface of thestruts. In some embodiments, an edge of the coaptation assistanceelement is curved. In some embodiments, one or more struts may curvelaterally from the annular hub toward the superior edge. In someembodiments, the superior edge of the coaptation assistance element cancurve upward from the annulus. In some embodiments, the superior edge ofthe coaptation assistance element can curve upward from the posteriorleaflet. In some embodiments, the superior edge of the coaptationassistance element can curve downward toward the annulus. In someembodiments, the superior edge of the coaptation assistance element cancurve downward toward the posterior leaflet. In some embodiments, one ormore struts may curve laterally from the annular hub toward the inferioredge. In some embodiments, the inferior edge of the coaptationassistance element can curve away from the posterior leaflet. In someembodiments, the inferior edge of the coaptation assistance element cancurve toward the posterior leaflet.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve in provided. The heart valve has anannulus. The coaptation assistance element can include a body thatincludes an annular section and a coaptation section. In someembodiments, the annular section is configured to be implanted within aheart superior to a valve annulus. In some embodiments, the coaptationzone configured to be implanted within a heart and traversing a plane ofthe valve annulus. The coaptation assistance element can include a firstcoaptation surface, and an opposed second surface. In some embodiments,each surface is bounded by a first lateral edge, a second lateral edge,an inferior edge, and a superior edge. In some embodiments, the superioredge forms a lip and cupped downward toward the inferior edge or upwardfrom the annular section. The coaptation assistance element can includea hub and an anchor coupled to the hub and carried by the annularsection. In some embodiments, the anchor is selectively deployable at afirst target location. The coaptation assistance element can include aplurality of struts extending radially outward from the hub. In someembodiments, the plurality of struts comprise at least a first strutresiding within the annular section and a second strut extending fromthe annular section to the coaptation section, wherein the second struthas a total length that is longer than that of the first strut, such as,for example, a total length that is about, or at least about 110%, 120%,130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 225%, 250% or more ofthe total length of the first strut. In some embodiments, the totallength of the second strut is between about 125% and about 300%, orbetween about 125% and 200% of the total length of the first strut.

In some embodiments, at least one strut of the plurality of struts has asharpened tip configured to engage tissue. In some embodiments, theplurality of struts comprises Nitinol. In some embodiments, the anchoris helical-shaped. The coaptation assistance element can include one ormore additional anchors. In some embodiments, the one or more additionalanchors are active anchors. In some embodiments, the hub comprises across-pin configured to extend through a helix of the anchor. In someembodiments, the hub is configured to mate with a delivery catheter,wherein the delivery catheter is configured to position the hub near thefirst target location. In some embodiments, the delivery catheter isconfigured to rotate the anchor independently of the hub. The coaptationassistance element can include a radiopaque marker. The coaptationassistance element can include a plurality of radiopaque markers nearthe superior edge. In some embodiments, the superior edge forming a lipis cupped downward toward the inferior edge. In some embodiments, thesuperior edge forming a lip is cupped upward from the annular section.In some embodiments, the hub extends upward from the annular section. Insome embodiments, the inferior edge curves backwards toward the hub.

In some embodiments, a method for treating mal-coaptation of a heartvalve in a patient is provided. The heart valve has an annulus. Theannulus further defines a valve plane, the valve plane separating anatrium proximally and a ventricle distally. The method can includecoupling a delivery catheter to a hub of a coaptation assistanceelement. The method can include positioning the hub near the annulus.The method can include rotating an anchor through the hub and into hearttissue distal to the annulus. The method can include expanding thecoaptation assistance element by allowing a plurality of struts toexpand radially outward from the hub.

In some embodiments, the coaptation assist body is suspended such thatthe coaptation surface coapts with a first leaflet and a leaflet surfaceof the coaptation assist body overlays a second leaflet such thatmal-coaptation is mitigated. The method can include engaging a sharpenedend of a strut of the plurality of struts with heart tissue distal tothe annulus. The method can include monitoring the position of thecoaptation assistance element with one or more markers. The method caninclude monitoring the position of the coaptation assistance elementwith a plurality of markers near a superior edge of the coaptationassistance element. In some embodiments, a tip of the anchor is recessedin the hub during positioning the hub near the annulus.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve of a heart is provided. The coaptationassistance element can include a first coaptation surface and an opposedsecond surface. The coaptation assistance element can include a firstlateral edge, a second lateral edge, an inferior edge, and a superioredge. The coaptation assistance element can include a superior zone andan inferior zone. In some embodiments, the superior zone is configuredto reside in the plane of an annulus of the heart valve. In someembodiments, the inferior zone comprises the first coaptation surfaceand the opposed second surface. In some embodiments, the inferior zonecomprises a laminate layer such that a thickness of the inferior zone isgreater than a thickness of a portion of the superior zone.

In some embodiments, the laminate layer comprises ePTFE. In someembodiments, the thickness of the inferior zone is at least about 25%thicker than the thickness of the portion of the superior zone. In someembodiments, the thickness of the inferior zone is at least about 50%thicker than the thickness of the portion of the superior zone. In someembodiments, the peripheral edge of the coaptation assistance elementcomprises a raised atraumatic edge surrounding only partially around thecoaptation assistance element. In some embodiments, the peripheral edgeof the coaptation assistance element comprises a raised atraumatic edgesurrounding only the inferior zone of the coaptation assistance element.In some embodiments, the raised edge comprises a suture. In someembodiments, the peripheral edge of the coaptation assistance elementcomprises spaced apart barbs extending radially outwardly from theperipheral edge of only the superior zone of the coaptation assistanceelement. The coaptation assistance element can include a hub spacedinward from each of the first lateral edge, the second lateral edge, theinferior edge, and the superior edge. The coaptation assistance elementcan include an active anchor configured to couple to the hub andconfigured to be rotated relative to the hub to selectively deploy theactive anchor at a first target location. The coaptation assistanceelement can include a plurality of struts spaced around the hub andextending outward from the hub, the plurality of struts comprising atleast a first strut configured to be implanted within the heart and asecond strut configured to be implanted within the heart such that thefirst coaptation surface coapts with a first leaflet of the heart valveand the opposed second surface overlays a second leaflet of the heartvalve. In some embodiments, the coaptation assistance element comprisesa layer of mesh.

In some embodiments, a coaptation assistance element delivery system fortreating mal-coaptation of a heart valve is provided. In someembodiments, the heart valve has an annulus. The coaptation assistanceelement delivery system can include a coaptation assistance elementcomprising a first surface and an opposed second surface. In someembodiments, each surface bounded by a first lateral edge, a secondlateral edge, an inferior edge, and a superior edge. The coaptationassistance element can include a hub. The coaptation assistance elementdelivery system can include a primary anchor disposed within a primaryanchor housing. In some embodiments, the primary anchor is configured toextend through the hub to engage the annulus. The coaptation assistanceelement delivery system can include a release wire extending through theprimary anchor housing and configured to be positioned adjacent to theannulus.

The coaptation assistance element delivery system can include a primaryanchor driver disposed within the primary anchor housing. In someembodiments, the primary anchor driver is configured to rotate, but nottranslate, relative to the primary anchor housing. In some embodiments,the primary anchor driver comprises two extensions, wherein the twoextensions are configured to engage a cross-bar of the primary anchor.The coaptation assistance element delivery system can include tworelease wires extending through the primary anchor housing. In someembodiments, the two release wires are configured to be positionedadjacent to the annulus, extending from the hub in opposite directions.In some embodiments, the two release wires cross. The coaptationassistance element delivery system can include a secondary anchor tetherextending through the coaptation assistance element. In someembodiments, the secondary anchor tether extends around the releasewire. The coaptation assistance element delivery system can include atleast two secondary anchor tethers extending through the coaptationassistance element. In some embodiments, at least two secondary anchortethers extend around the release wire. In some embodiments, at leastone secondary anchor tether extends around the release wire and at leastone secondary anchor tether extends around a second release wire. Thecoaptation assistance element delivery system can include a secondaryanchor guide rail. In some embodiments, the secondary anchor guide railis configured to lock a secondary anchor driver to a secondary anchor.In some embodiments, the secondary anchor guide rail is configured toprevent entanglement between a secondary anchor and an adjacentsecondary anchor tether. In some embodiments, the secondary anchor guiderail is configured to slide along a secondary anchor tether to deliver asecondary anchor. The coaptation assistance element delivery system caninclude a secondary anchor driver. In some embodiments, the secondaryanchor driver comprises at least one locking tab configured to engage awindow of a secondary anchor. The coaptation assistance element deliverysystem can include a secondary anchor. In some embodiments, thesecondary anchor is configured to be delivered by sliding the secondaryanchor along a secondary anchor tether looped around the release wire.In some embodiments, the secondary anchor is configured to be rotated toengage the annulus. In some embodiments, the secondary anchor has asmaller diameter than the primary anchor. In some embodiments, therelease wire is configured to be retracted after the primary anchorengages the annulus. In some embodiments, the release wire is configuredto be retracted after the primary anchor and at least one secondaryanchor engages the annulus. In some embodiments, the primary anchorhousing is configured to be retracted after the release wire isretracted, wherein the primary anchor driver retracts with the primaryanchor housing. In some embodiments, the trajectory of the primaryanchor is through the hub. In some embodiments, a cross-pin of the hubis configured to couple the primary anchor to the coaptation assistanceelement. In some embodiments, at least one secondary anchor isconfigured to have two or more trajectories. In some embodiments, thetrajectory of at least one secondary anchor is determined by theorientation of a respective secondary anchor guide rail. In someembodiments, the secondary anchor guide rail comprises a curved distalend, wherein the curved distal end defines the trajectory. Thecoaptation assistance element delivery system can include a proximalassembly configured to lock the position of a secondary anchor guiderail relative to a secondary anchor to prevent entanglement of asecondary anchor tether. The coaptation assistance element deliverysystem can include a proximal assembly configured to lock the positionof a secondary anchor guide rail relative to a secondary anchor driverto facilitate coupling of the secondary anchor driver to a secondaryanchor. The coaptation assistance element delivery system can include aproximal assembly configured to lock the position of a secondary anchortether, wherein the secondary anchor tether is coupled to the releasewire. The coaptation assistance element delivery system can include aproximal assembly configured to lock the position of a secondary anchortether to apply tension to the secondary anchor tether to define atrajectory for a secondary anchor. The coaptation assistance elementdelivery system can include an anti-rotation feature. In someembodiments, a secondary anchor comprises the anti-rotation feature.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve is provided. In some embodiments, theheart valve has an annulus. The coaptation assistance element caninclude a first surface and an opposed second surface, each surfacebounded by a first lateral edge, a second lateral edge, an inferioredge, and a superior edge. The coaptation assistance element can includea hub. The coaptation assistance element can include a plurality ofstruts spaced around the hub and extending outward from the hub, theplurality of struts comprising at least a first strut configured to beimplanted within a heart superior to a valve annulus and a second strutconfigured to be implanted within a heart and traversing a plane of thevalve annulus.

In some embodiments, the coaptation assistance element comprises atleast one layer of ePTFE. In some embodiments, the coaptation assistanceelement comprises at least one layer of mesh. In some embodiments, thecoaptation assistance element comprises at least one layer of UHMWPEmesh. In some embodiments, the coaptation assistance element comprisesat least one layer of fabric. In some embodiments, the coaptationassistance element comprises at least one layer of polyester fabric. Insome embodiments, the first surface is reinforced. In some embodiments,the second surface is reinforced. In some embodiments, a ventricularsurface is reinforced. In some embodiments, a coaptation surface isreinforced. In some embodiments, an anchor zone is reinforced. In someembodiments, at least one edge comprises a raised edge. In someembodiments, the coaptation assistance element is configured to minimizecontact with a posterior leaflet. In some embodiments, the coaptationassistance element is configured to engage and embed within the annulus.

In some embodiments, a method of delivering a coaptation assistanceelement is provided. The method can include delivering a coaptationassistance element to a heart of a patient. In some embodiments, thecoaptation assistance element is coupled to a coaptation assistanceelement delivery system. In some embodiments, the coaptation assistanceelement delivery system comprising a primary anchor disposed within aprimary anchor housing. In some embodiments, the coaptation assistanceelement delivery system comprising at least one release wire. The methodcan include expanding the coaptation assistance element within theheart. The method can include anchoring the coaptation assistanceelement to an annulus of the heart valve by rotating the primary anchor.

The method can include rotating a primary anchor driver within theprimary anchor housing. In some embodiments, the at least one releasewire is coupled to the primary anchor housing and extends under thecoaptation assistance element when the coaptation assistance element isexpanded. In some embodiments, at least one secondary anchor tetherextends through the coaptation assistance element when the coaptationassistance element is expanded. In some embodiments, at least onesecondary anchor tether loops around the at least one release wire whenthe coaptation assistance element is expanded. In some embodiments, thecoaptation assistance element is delivered in a low profileconfiguration. In some embodiments, the at least one release wire isconfigured to maintain the position of the primary anchor housingrelative to the coaptation assistance element. In some embodiments, theat least one release wire is configured to maintain the position of atleast one secondary anchor tether relative to the coaptation assistanceelement. In some embodiments, the coaptation assistance element isdelivered via a delivery catheter. In some embodiments, a telescopingaction is configured to position the coaptation assistance elementrelative to a location to engage the primary anchor with the annulus.The method can include rotating the primary anchor to engage theannulus. The method can include rotating a primary anchor driver withinthe primary anchor housing, wherein the primary anchor driver isconfigured to rotate by not translate relative to the primary anchorhousing. The method can include sliding a secondary anchor assemblytoward the annulus, along a secondary anchor tether. The method caninclude maintaining engagement between a secondary anchor driver and asecondary anchor with a secondary anchor guide rail. The method caninclude preventing entanglement between a secondary anchor and asecondary anchor tether with a secondary anchor guide rail. The methodcan include coupling a secondary anchor driver to a secondary anchor.The method can include partially retracting a secondary anchor guiderail before the secondary anchor engages tissue. The method can includeretracting a secondary anchor guide rail after the secondary anchorengages tissue. The method can include retracting a secondary anchordriver after retracting a secondary anchor guide rail. The method caninclude retracting the at least one release wire.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve is provided, the heart valve having anannulus. The coaptation assistance element can include a firstcoaptation surface and an opposed second surface, each surface boundedby a first lateral edge, a second lateral edge, an inferior edge, and asuperior edge. The coaptation assistance element can include a hub. Thecoaptation assistance element can include an anchor coupled to the huband configured to be rotated relative to the hub to selectively deploythe anchor at a first target location. The coaptation assistance elementcan include a plurality of struts spaced around the hub and extendingoutward from the hub. In some embodiments, the plurality of strutscomprises at least a first strut configured to be implanted within aheart superior to a valve annulus and a second strut configured to beimplanted within a heart and traversing a plane of the valve annulus.

In some embodiments, the second strut has a total length that is longerthan that of the first strut. In some embodiments, the hub is spacedradially inward from each of the first lateral edge, the second lateraledge, the inferior edge, and the superior edge. In some embodiments, theplurality of struts are spaced circumferentially around the hub. In someembodiments, the superior edge forms a lip cupped downward toward theinferior edge or upward from the inferior edge. In some embodiments, atleast one strut of the plurality of struts has a sharpened tipconfigured to engage tissue. In some embodiments, the plurality ofstruts comprise Nitinol. In some embodiments, the anchor ishelical-shaped. The coaptation assistance element can include one ormore additional anchors. In some embodiments, the one or more additionalanchors are active anchors. In some embodiments, the hub comprises across-pin configured to extend through a helix of the anchor. In someembodiments, the hub is configured to mate with a delivery catheter,wherein the delivery catheter is configured to position the hub near thefirst target location. In some embodiments, the delivery catheter isconfigured to rotate the anchor independently of the hub. The coaptationassistance element can include a radiopaque marker. The coaptationassistance element can include a plurality of radiopaque markers nearthe superior edge. In some embodiments, the lip is cupped downwardtoward the inferior edge. In some embodiments, the lip is cupped upwardfrom the inferior edge. In some embodiments, the hub extends upward fromthe first coaptation surface. In some embodiments, the inferior edgecurves backwards toward the hub. In some embodiments, the hub istubular. In some embodiments, the struts and the hub are integrallyformed. In some embodiments, the coaptation assistance element isconfigured to be collapsed relative to the hub. In some embodiments, theactive anchor is configured to be selectively coupled and decoupled fromtissue.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve is provided, the heart valve having anannulus. The coaptation assistance element can include a firstcoaptation surface and an opposed second surface. In some embodiments,each surface bounded by a first lateral edge, a second lateral edge, aninferior edge, and a superior edge. The coaptation assistance elementcan include a hub. The coaptation assistance element can include ananchor coupled to the hub. In some embodiments, the anchor is configuredto be rotated in a first direction to selectively deploy the activeanchor to engage tissue. In some embodiments, the active anchor isconfigured to be rotated in a second direction, opposite the firstdirection, to selectively disengage tissue. The coaptation assistanceelement can include a plurality of struts spaced around the hub. In someembodiments, the plurality of struts comprises at least a first strutconfigured to be implanted within a heart superior to a valve annulusand a second strut configured to be implanted within a heart andtraversing a plane of the valve annulus.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve is provided. In some embodiments, theheart valve has an annulus, an anterior leaflet, and a posteriorleaflet. The coaptation assistance element can include a firstcoaptation surface and an opposed second surface. In some embodiments,each surface bounded by a first lateral edge, a second lateral edge, aninferior edge, and a superior edge. The coaptation assistance elementcan include a hub. The coaptation assistance element can include ananchor coupled to the hub and configured to be rotated relative to thehub to selectively deploy the anchor at a first target location. In someembodiments, the anchor is configured to be selectively deployed in theannulus. The coaptation assistance element can include a plurality ofstruts spaced around the hub. In some embodiments, the plurality ofstruts comprising at least a first strut configured to be implantedwithin a heart superior to a valve annulus and a second strut configuredto be implanted within a heart and traversing a plane of the valveannulus.

In some embodiments, a coaptation assistance element delivery system fortreating mal-coaptation of a heart valve, the heart valve having anannulus, is provided. The coaptation assistance element delivery systemcan include a coaptation assistance element comprising a first surfaceand an opposed second surface. In some embodiments, each surface boundedby a first lateral edge, a second lateral edge, an inferior edge, and asuperior edge. In some embodiments, the coaptation assistance elementcomprises a hub. The coaptation assistance element delivery system caninclude a first anchor disposed within a first anchor housing. In someembodiments, the first anchor is configured to extend through the hub toengage the annulus. The coaptation assistance element delivery systemcan include a release wire extending through the first anchor housingand configured to be positioned adjacent to the annulus.

In some embodiments, the coaptation assistance element delivery systemcan include a radiopaque marker. In some embodiments, the coaptationassistance element delivery system can include a second anchor tetherextending through the coaptation assistance element and around therelease wire. In some embodiments, the radiopaque marker is crimped tothe second anchor tether. In some embodiments, the radiopaque marker isconfigured for visual confirmation of an anchoring depth of a secondanchor. In some embodiments, the coaptation assistance element deliverysystem can include a second anchor. In some embodiments, the secondanchor comprises a first helical portion having a first pitch and asecond helical portion having a second, smaller pitch. In someembodiments, the second helical portion is configured to lock with thecoaptation assistance element. In some embodiments, the second anchorincludes a locking segment and an anchoring segment, the locking segmentcomprising having a smaller pitch than the anchoring segment. In someembodiments, the second anchor is configured to be delivered by slidingthe second anchor along a second anchor tether looped around the releasewire. In some embodiments, the second anchor is configured to bedelivered by sliding the second anchor along a second anchor guide rail,wherein the second anchor guide rail guides the trajectory of the secondanchor. In some embodiments, the second anchor is configured to berotated to engage the annulus. In some embodiments, the second anchor isconfigured to have two or more trajectories. In some embodiments, thetrajectory of the second anchor is determined by the orientation of arespective second anchor guide rail. In some embodiments, the coaptationassistance element delivery system can include a first anchor driverdisposed within the first anchor housing, wherein the first anchordriver is configured to rotate, but not translate, relative to the firstanchor housing. In some embodiments, the coaptation assistance elementdelivery system can include a second anchor guide rail. In someembodiments, the second anchor guide rail is configured to lock a secondanchor driver to a second anchor. In some embodiments, the second anchorguide rail is configured to slide along a second anchor tether todeliver a second anchor. In some embodiments, the second anchor guiderail comprises a distal section with a bend between 30 and 90 degrees.In some embodiments, the bend determines the trajectory of a secondanchor delivered along the second anchor guide rail.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1F schematically illustrate some of the tissues of the heartand mitral valve, as described in the Background section and below, andwhich may interact with the implants and systems described herein.

FIG. 2A illustrates a simplified cross-section of a heart, schematicallyshowing mitral valve function during diastole.

FIG. 2B illustrates a simplified cross-section of a heart, schematicallyshowing mitral valve function during systole.

FIGS. 3A-3B illustrate a simplified cross-section of a heart,schematically showing mitral valve regurgitation during systole in thesetting of mal-coaptation of the mitral valve leaflets.

FIG. 4A illustrates a stylized cross section of a heart, showing mitralvalve mal-coaptation in the setting of functional mitral valveregurgitation.

FIG. 4B illustrates a stylized cross section of a heart, showing mitralvalve mal-coaptation in the setting of degenerative mitral valveregurgitation.

FIG. 5A illustrates a perspective view of an embodiment of a coaptationassistance element.

FIG. 5B illustrates the top view of the coaptation assistance element ofFIG. 5A.

FIGS. 5C-5D illustrates an embodiment of the struts of a coaptationassistance element.

FIGS. 5E-5G illustrate the coaptation assistance element of FIG. 5Awithout annular anchor site.

FIGS. 5H-5J illustrate the coaptation assistance element of FIG. 5A withleaflet anchor sites.

FIG. 5K illustrates dimensions of the coaptation assistance element ofFIG. 5A.

FIG. 6 illustrates a perspective view of an embodiment of a coaptationassistance element.

FIG. 7A illustrates a perspective view of an embodiment of a coaptationassistance element showing a first surface disposed toward amal-coapting native leaflet.

FIG. 7B illustrates another perspective view of the coaptationassistance element of FIG. 7A showing a second surface which can includea coaptation surface.

FIG. 7C illustrates a top view of the coaptation assistance element ofFIG. 7A.

FIG. 7D illustrates the coaptation assistance element of FIG. 7Aimplanted within a model of a mitral valve.

FIG. 7E illustrates a top view of the coaptation assistance element ofFIG. 7A implanted within a model of a mitral valve.

FIG. 8A schematically illustrates an embodiment of control handle of adelivery system for a transcatheter technique.

FIG. 8B schematically illustrates a top view and a side view acoaptation assistance element coupled to the delivery system of FIG. 8A.

FIG. 8C schematically illustrates the connection between an annular hubof the coaptation assistance element and a tip of the delivery catheter.

FIG. 9A schematically illustrates the anchor manipulation of thedelivery system of FIG. 8A.

FIGS. 9B-9E schematically illustrates embodiments of the connectionbetween an annular anchor and a driver.

FIG. 10 schematically illustrates a method for a transcatheter techniqueshowing transseptal crossing.

FIG. 11 schematically illustrates a method for a transcatheter techniqueshowing initial coaptation assistance element advancement.

FIG. 12 schematically illustrates a method for a transcatheter techniqueshowing partial coaptation assistance element opening.

FIG. 13 schematically illustrates a method for a transcatheter techniqueshowing coaptation assistance element collapsing.

FIG. 14 schematically illustrates a method for a transcatheter techniqueshowing a cross-sectional view of the coaptation assistance element.

FIG. 15 schematically illustrates a method for a transcatheter techniqueshowing secondary anchor placement.

FIG. 16 illustrates a method for implant delivery showing loading of animplant.

FIG. 17 illustrates a method for inserting an introducer.

FIG. 18 illustrates a method for connecting the introducer of FIG. 17 toa transseptal sheath.

FIG. 19 illustrates a method for advancing the transseptal sheath ofFIG. 18 .

FIG. 20 illustrates a method for positioning the transseptal sheath ofFIG. 19 .

FIG. 21 illustrates a method for delivering an anchor.

FIGS. 22A-22D illustrate a method for deploying the implant.

FIG. 23 illustrates a method for utilizing one or more secondary anchorguidewires.

FIG. 24 illustrates a method for removing an anchor driver.

FIG. 25 illustrates a method for advancing secondary anchor guiderails.

FIG. 26 illustrates a method for delivering a secondary anchor.

FIG. 27 illustrates a method for inserting a secondary anchor.

FIG. 28 illustrates a method for delivering another secondary anchor.

FIG. 29 illustrates the anchored implant with guidewires.

FIG. 30 illustrates the anchored implant.

FIGS. 31A-31F illustrate a method for retrieving the implant.

FIG. 32 illustrates a method for inserting a secondary anchor.

FIG. 33 illustrates a method for delivering another secondary anchor.

FIG. 34 illustrates a method for inserting another secondary anchor.

FIG. 35 illustrates the anchored implant.

FIG. 36 illustrates an embodiment of lamination.

FIG. 37 illustrates an embodiment of lamination.

FIG. 38 illustrates an embodiment of 3D forming.

FIG. 39 illustrates an embodiment of 3D forming.

FIG. 40 illustrates an implant.

FIG. 41 illustrates an embodiment of a barb.

FIGS. 42A-42I illustrate an embodiment of an implant delivery system.

FIGS. 43A-43E illustrate an embodiment of an implant delivery system.

FIGS. 44A-44E illustrate an embodiment of an implant delivery system.

FIGS. 45A-45K illustrate an embodiment of an implant delivery system.

FIGS. 46A-46C illustrate an embodiment of an anchor delivery system.

FIGS. 47A-47E illustrate views of an embodiment of a coaptationassistance element.

FIG. 48 illustrates an embodiment of implant construction.

FIG. 49 illustrates an embodiment of an implant delivery system.

FIG. 50 illustrates a method of delivery.

FIG. 51 illustrates an embodiment of a primary anchor driver.

FIG. 52 illustrates an embodiment of a secondary anchor guide rail.

FIGS. 53A-53B illustrate an embodiment of a secondary anchor guide railto prevent entanglement.

FIG. 54 illustrates an embodiment of a secondary anchor guide rail tofacilitate the trajectory for a secondary anchor.

FIGS. 55A-55C illustrate an embodiment of a proximal assembly.

FIG. 56 illustrates an embodiment of an anti-rotation feature.

FIGS. 57A-57B illustrates an embodiment of posterior leafletaugmentation and restoration.

FIGS. 58A-58J illustrate an embodiment of an implant delivery system.

FIGS. 59A-59B illustrate an embodiment of a secondary anchor.

FIG. 60 illustrates an embodiment of the secondary anchor of FIG. 59Aand an implant.

FIG. 61 illustrates an embodiment of a mitral valve in systole anddiastole.

FIGS. 62A-62C illustrates an embodiment of an implant.

FIG. 63 illustrates an embodiment of the implant of FIG. 62A positionedin the mitral valve in systole and diastole.

FIGS. 64A-64D illustrates an embodiment of an implant.

FIG. 65 illustrates an embodiment of the implant of FIG. 64A positionedin the mitral valve in systole and diastole.

FIGS. 66A-66D illustrates an embodiment of an implant.

FIG. 67A-67B illustrates an embodiment of the implant of FIG. 66Adelivered to the mitral valve.

FIG. 68 illustrates an embodiment of the implant of FIG. 66A positionedin the mitral valve in systole and diastole.

DETAILED DESCRIPTION

The present invention, in some embodiments, generally provides improvedmedical devices, systems, and methods, often for treatment of mitralvalve regurgitation and other valve diseases including tricuspidregurgitation. While the description that follows includes reference tothe anterior leaflet in a valve with two leaflets such as the mitralvalve, it is understood that “anterior leaflet” could refer to one ormore leaflets in valve with multiple leaflets. For example, thetricuspid valve has 3 leaflets so the “anterior” could refer to one ortwo of the medial, lateral, and posterior leaflets. The coaptationassistance elements described herein will generally include a coaptationassist body (sometimes referred to herein as a valve body) which isgenerally along the blood flow path as the leaflets of the valve moveback and forth between an open-valve configuration (with the anteriorleaflet separated from valve body) and a closed-valve configuration(with the anterior leaflet engaging opposed surfaces of the valve body).The valve body will be disposed between the native leaflets to close thegap caused by mal-coaptation of the native leaflets by providing asurface for at least one of the native leaflets to coapt against, whileeffectively replacing a second native leaflet in the area of the valvewhich, were it functioning normally, it would occlude during systole.The gaps may be lateral (such as may be caused by a dilated leftventricle and/or mitral valve annulus) and/or axial (such as where oneleaflet prolapses or is pushed by fluid pressure beyond the annulus whenthe valve should close). In some embodiments, the coaptation assistelements may completely assist one, two, or more valve leaflets, or insome embodiments partially assist a valve leaflet, for example, coveringonly one or more of the A1, A2, and/or A3 scallops of the anteriorleaflet, and/or one or more of the P1, P2, and/or P3 scallops of theposterior leaflet.

Among other uses, the coaptation assistance elements, and methodsdescribed herein may be configured for treating functional and/ordegenerative mitral valve regurgitation (MR) by creating an artificialor new coaptation zone within which at least one of the native mitralvalve leaflets can seal. The structures and methods herein will largelybe tailored to this application, though alternative embodiments might beconfigured for use in other valves of the heart and/or body, includingthe tricuspid valve, valves of the peripheral vasculature, the inferiorvena cava, or the like.

Referring to FIGS. 1A-1D, the four chambers of the heart are shown, theleft atrium 10, right atrium 20, left ventricle 30, and right ventricle40. The mitral valve 60 is disposed between the left atrium 10 and leftventricle 30. Also shown are the tricuspid valve 50 which separates theright atrium 20 and right ventricle 40, the aortic valve 80, and thepulmonary valve 70. The mitral valve 60 is composed of two leaflets, theanterior leaflet 12 and posterior leaflet 14. In a healthy heart, thetwo leaflets appose during systole at the coaptation zone 16.

The fibrous annulus 120, part of the cardiac skeleton, providesattachment for the two leaflets of the mitral valve, referred to as theanterior leaflet 12 and the posterior leaflet 14. The leaflets areaxially supported by attachment to the chordae tendinae 32. The chordae,in turn, attach to one or both of the papillary muscles 34, 36 of theleft ventricle. In a healthy heart, the chordae support structurestether the mitral valve leaflets, allowing the leaflets to open easilyduring diastole but to resist the high pressure developed duringventricular systole. In addition to the tethering effect of the supportstructure, the shape and tissue consistency of the leaflets helpspromote an effective seal or coaptation. The leading edges of theanterior and posterior leaflet come together along a funnel-shaped zoneof coaptation 16, with a lateral cross-section 160 of thethree-dimensional coaptation zone (CZ) being shown schematically in FIG.1E.

The anterior and posterior mitral leaflets are dissimilarly shaped. Theanterior leaflet is more firmly attached to the annulus overlying thecentral fibrous body (cardiac skeleton), and is somewhat stiffer thanthe posterior leaflet, which is attached to the more mobile posteriormitral annulus. Approximately 80 percent of the closing area is theanterior leaflet. Adjacent to the commissures 110, 114, on or anteriorto the annulus 120, lie the left (lateral) 124 and right (septal) 126fibrous trigones which are formed where the mitral annulus is fused withthe base of the non-coronary cusp of the aorta (FIG. 1F). The fibroustrigones 124, 126 form the septal and lateral extents of the centralfibrous body 128. The fibrous trigones 124, 126 may have an advantage,in some embodiments, as providing a firm zone for stable engagement withone or more annular or atrial anchors. The coaptation zone CL betweenthe leaflets 12, 14 is not a simple line, but rather a curvedfunnel-shaped surface interface. The first 110 (lateral or left) andsecond 114 (septal or right) commissures are where the anterior leaflet12 meets the posterior leaflet 14 at the annulus 120. As seen mostclearly in the axial views from the atrium of FIGS. 1C, 1D, and 1F, anaxial cross-section of the coaptation zone generally shows the curvedline CL that is separated from a centroid of the annulus CA as well asfrom the opening through the valve during diastole CO. In addition, theleaflet edges are scalloped, more so for the posterior versus theanterior leaflet. Mal-coaptation can occur between one or more of theseA-P (anterior-posterior) segment pairs A1/P1, A2/P2, and A3/P3, so thatmal-coaptation characteristics may vary along the curve of thecoaptation zone CL.

Referring now to FIG. 2A, a properly functioning mitral valve 60 of aheart is open during diastole to allow blood to flow along a flow pathFP from the left atrium toward the left ventricle 30 and thereby fillthe left ventricle. As shown in FIG. 2B, the functioning mitral valve 60closes and effectively seals the left ventricle 30 from the left atrium10 during systole, first passively then actively by increase inventricular pressure, thereby allowing contraction of the heart tissuesurrounding the left ventricle to advance blood throughout thevasculature.

Referring to FIGS. 3A-3B and 4A-4B, there are several conditions ordisease states in which the leaflet edges of the mitral valve fail tooppose sufficiently and thereby allow blood to regurgitate in systolefrom the ventricle into the atrium. Regardless of the specific etiologyof a particular patient, failure of the leaflets to seal duringventricular systole is known as mal-coaptation and gives rise to mitralregurgitation.

Generally, mal-coaptation can result from either excessive tethering bythe support structures of one or both leaflets, or from excessivestretching or tearing of the support structures. Other, less commoncauses include infection of the heart valve, congenital abnormalities,and trauma. Valve malfunction can result from the chordae tendinaebecoming stretched, known as mitral valve prolapse, and in some casestearing of the chordae 215 or papillary muscle, known as a flail leaflet220, as shown in FIG. 3A. Or if the leaflet tissue itself is redundant,the valves may prolapse so that the level of coaptation occurs higherinto the atrium, opening the valve higher in the atrium duringventricular systole 230. Either one of the leaflets can undergo prolapseor become flail. This condition is sometimes known as degenerativemitral valve regurgitation.

In excessive tethering, as shown in FIG. 3B, the leaflets of a normallystructured valve may not function properly because of enlargement of orshape change in the valve annulus: so-called annular dilation 240. Suchfunctional mitral regurgitation generally results from heart musclefailure and concomitant ventricular dilation. And the excessive volumeload resulting from functional mitral regurgitation can itselfexacerbate heart failure, ventricular and annular dilation, thusworsening mitral regurgitation.

FIG. 4A-4B illustrate the backflow BF of blood during systole infunctional mitral valve regurgitation (FIG. 4A) and degenerative mitralvalve regurgitation (FIG. 4B). The increased size of the annulus in FIG.4A, coupled with increased tethering due to hypertrophy of the ventricle320 and papillary muscle 330, prevents the anterior leaflet 312 andposterior leaflet 314 from apposing, thereby preventing coaptation. InFIG. 4B, the tearing of the chordae 215 causes prolapse of the posteriorleaflet 344 upward into the left atrium, which prevents appositionagainst the anterior leaflet 342. In either situation, the result isbackflow of blood into the atrium, which decreases the effectiveness ofleft ventricle compression.

Further description of coaptation assistance elements, tools, anchors,features, systems, and methods, which can be utilized in conjunctionwith the disclosure herein, can be found in the following applications,each of which is incorporated by reference in their entirety: U.S.patent application Ser. No. 13/099,532, filed May 3, 2011; U.S. patentapplication Ser. No. 13/531,407, filed Jun. 22, 2012; U.S. patentapplication Ser. No. 14/313,975, filed Jun. 24, 2014; U.S. patentapplication Ser. No. 14/742,199, filed Jun. 17, 2015; U.S. patentapplication Ser. No. 14/749,344, filed Jun. 24, 2015; and U.S. patentapplication Ser. No. 10/419,706, filed Apr. 18, 2003.

In some embodiments, the coaptation assistance elements described hereinmay be deployed to overlie the posterior leaflet, the chordae andpapillary muscle. In some embodiments, the coaptation assistance elementattaches superiorly to the posterior aspect of the annulus andinferiorly to the posterior aspect of the left ventricle via annularanchor and/or ventricular anchor. In other embodiments, more than oneannular anchor and/or more than one ventricular anchor may be used toattach the coaptation assistance element. In some elements, the one ormore annular anchors may be replaced by or supplemented with one or moreatrial or commissural anchors, which can be annular in some embodiments.The coaptation assistance element may attach to the superior surface ofthe posterior annulus, the posterior atrial wall, or the annulus itself.A coaptation zone has been established between the coaptation assistanceelement and the native anterior leaflet. Similar coaptation assistanceelements can be used in both functional and degenerative mitral valveregurgitation because the failure of leaflet coaptation occurs in both,regardless of the mechanism behind the dysfunction. In some embodiments,differently sized coaptation assistance elements can be placed such thatthe native anterior leaflet apposes the coaptation element at theappropriately established coaptation point, blocking flow of bloodduring contraction of the ventricle.

A variety of sizes of coaptation assistance elements may be provided,with differing dimensions configured to fit varying anatomies. Forexample, there may be a height, which measures from the superior annularattachment site to the inferior-most edge of the coaptation assistanceelement in a plane basically perpendicular to the plane defined by theannulus of the valve, a depth between the coaptation point and thesuperior attachment site, and a projection between the posterior wall atthe level of the coaptation point and the coaptation point. There isalso a medial-lateral diameter of the coaptation assistance element,typically larger in functional MR. During diastole, the coaptationassistance element may stay in substantially the same position, whilemovement of the native anterior leaflet opens the valve, permitting flowof blood from the left atrium to the left ventricle with minimalrestriction. In some embodiments, the surface of the coaptationassistance element may balloon or stretch upwards during ventricularsystole, while the anchors remain unmoved. This may be advantageous asenhancing the seal between the anterior or coaptation surface of theelement and the native leaflet at the coaptation zone during systole.During diastole, the surface may return to an initial position in whichit lies more anteriorly, toward the anterior leaflet. This may providean improved blood flow path between the atrium and ventricle duringdiastole, improving outflow from the atrium past the coaptation assistelement.

In some methods of use, the native posterior leaflet is left inposition, and the coaptation assistance element is attached superiorlyto the posterior annulus or adjacent atrial wall. Many possiblealternate embodiments may have differing attachment mechanisms. In othermethods of use, the posterior leaflet is not present, having beenremoved surgically or the result of disease. In some methods of use, thenative leaflet attaches to the posterior surface of the coaptationassistance element. In some methods of use, the coaptation assistanceelement may attach to the anterior surface of the posterior leaflet,rather than the annulus or atrial wall. These are some examples ofvariations, but still others are contemplated. In some methods of use,an anchoring structure (not shown) could pass from the coaptationassistance element, through the atrial wall into the coronary sinus,wherein the anchoring structure attaches to a mating structure in thecoronary sinus. In some methods of use, the anchoring structure, whichcould be a mechanical structure or a simple suture, can pass through theatrial wall and be anchored by a knot or mechanical element, such as aclip, on the epicardial surface of the heart. Similarly, attachmentinferiorly may be to the ventricular muscle, through the apex into theepicardium or pericardium and secured from outside, or at otherattachment sites using alternative attachment means.

The coaptation assistance element described herein may exhibit a numberof desirable characteristics. Some embodiments need not rely onreshaping of the mitral annulus (such as by thermal shrinking of annulartissue, implantation of an annular ring prosthesis, and/or placement ofa cinching mechanism either above or beneath the valve plane, or in thecoronary sinus or related blood vessels). Advantageously, they also neednot disrupt the leaflet structure or rely on locking together or fusingof the mitral leaflets. Many embodiments can avoid reliance onventricular reshaping, and after implantation represent passiveimplanted devices with limited excursion which may result in very longfatigue life. Thus, the coaptation assistance element can be securedacross a posterior leaflet while otherwise leaving native heart (e.g.,ventricular, mitral annulus, etc.) anatomy intact.

Mitigation of mitral valve mal-coaptation may be effective irrespectiveof which leaflet segment(s) exhibit mal-coaptation. The treatmentsdescribed herein will make use of coaptation assistance elements thatare repositionable during the procedure, and even removable aftercomplete deployment and/or tissue response begins or is completed, oftenwithout damaging the valve structure. Nonetheless, the coaptationassistance element described herein may be combined with one or moretherapies that do rely on one or more of the attributes described aboveas being obviated. The coaptation assistance element can exhibit benigntissue healing and rapid endothelialization which inhibits migration,thromboembolism, infection, and/or erosion. In some cases, thecoaptation assistance element will exhibit no endothelialization but itssurface will remain inert, which can also inhibit migration,thromboembolism, infection and/or erosion.

FIGS. 5A-5B show two views of an embodiment of a coaptation assistanceelement 500. The coaptation assistance element 500 can include a firstsurface 505 disposed toward a mal-coapting native leaflet, in theinstance of a mitral valve, the posterior leaflet and a second surface515 which may be disposed toward the anterior leaflet. The secondsurface 515 can include a coaptation surface 560. The superior edge 540of the coaptation assistance element 500 may be curved to match thegeneral shape of the annulus or adjoining atrial wall, as describedherein. The superior edge 540 can be curved downward, toward theposterior leaflet, as shown in FIG. 5A, or curved upward, toward theatrial wall to match the general shape of the left atrial wall, as shownin FIG. 6 and described herein.

The coaptation assistance element 500 can have a geometry which permitsit to traverse the valve between attachment sites in the atrium andventricle. In some embodiments, the attachment sites are only in theatrium. In some embodiments, the attachment sites are only near theannulus and the commissures of the valve. The coaptation assistanceelement 500 can be unattached near the inferior edge 580. The coaptationassistance element 500 does not require ventricular attachment. In someembodiments, the geometry of the coaptation assistance element 500 helpsto maintain the position of the coaptation assistance element 500 withinthe valve. In some embodiments, the coaptation assistance element 500 iscurved to cup the posterior leaflet. In some embodiments, the coaptationassistance element 500 is curved backwards toward the superior edge 540.The coaptation assistance element 500 may provide the coaptation surface560 for the anterior leaflet to coapt against. FIGS. 5A and 5Billustrate that geometry.

In some methods of use, the posterior leaflet can be left intact. Thecoaptation assistance element 500 may attach to the atrium or annulussuch that it effectively seals off the posterior leaflet. In somemethods of use, the posterior leaflet can be removed. The coaptationassistance element 500 may, in the instance that the leaflet is or hasbeen removed, replace the posterior leaflet. In some embodiments, thecoaptation assistance element 500 only requires annular attachment. Insome embodiments, the coaptation assistance element 500 only requiresattachment at a single point. The single point may be a central locationof the coaptation assistance element 500, for instance, acentrally-located hub. In some embodiments, the coaptation assistanceelement 500 may attach to the atrium or annulus along an edge. In someembodiments, the coaptation assistance element 500 may attach to theatrium or annulus at a location separated from the edge of thecoaptation assistance element 500, for instance, at a centrally-locatedhub.

The coaptation assistance element 500 can include an annular hub 520engaging an annular anchor 800. The annular anchor 800 may be engaged ata proximal end by a driver, described herein. The annular anchor 800 caninclude a sharpened tip to engage tissue. In some methods of use, thetip of the annular anchor 800 is within the annular hub 520 duringdelivery of the coaptation assistance element 500. In some methods ofuse, the tip of the annular anchor 800 is above the annular section 510during delivery. The tip of the annular anchor 800 can remain recessedwithin the annular hub 520 until the annular anchor 800 is rotated toengage tissue. In some embodiments, the coaptation assistance element500 can be assembled extra-corporeally, engaging the annular anchor 800to the coaptation assistance element 500 via the annular hub 520 and thedrivers to the annular anchor 800. The drivers can then be withdrawninto a delivery catheter, with the coaptation assistance element 500 ina collapsed position. The drivers may be separately manipulated by theoperator to place the annular anchor 800 in the appropriate position.Alternatively, the annular anchor 800 may be engaged to the coaptationassistance element 500 and/or the driver sequentially, either before orafter deployment through the delivery catheter. The coaptationassistance element 500 after placement can entirely cover the posteriorleaflet so that the coaptation assistance element 500 coapts with theanterior leaflet during systole and, with the native anterior leaflet,maintains the valve seal at the annular ring.

In some embodiments, the annular anchor 800 is an active anchor. Theuser can selectively engage or disengage the annular anchor 800 fromtissue. Unlike barbs or other passive anchors, an active anchor can beactivated such as by rotation in order to engage tissue. The annularanchor 800 allows placement of the coaptation assistance element 500prior to engagement of the annular anchor 800. The coaptation assistanceelement 500 can make contact with the tissue without any adhesion of theannular anchor 800. In some embodiments, the annular anchor 800 andcorresponding hub 520 are centrally located on the coaptation assistanceelement 500. The annular anchor 800 and corresponding hub 520 are spacedapart from any edge of the coaptation assistance element 500. Thelocation of the annular anchor 800 and corresponding hub 520 can be at aneutral center to prevent swinging of the coaptation assistance element500 when the coaptation assistance element 500 is held by the annularhub 520. The corresponding hub 520 provides a convenient location tohold and move the coaptation assistance element 500.

The annular hub 520 may have a built-in or coupled annular anchor 800.In some embodiments, the annular anchor 800 can be retained by across-pin, described herein, within the annular hub 520. The cross-pinmay pass through the helical structure of the annular anchor 800 toprevent dislodgement of the annular anchor 800 from the annular hub 520by a blunt force. The annular anchor 800 may comprise a helix rotatablewith respect to the annular hub 520. In some embodiments, other anchorsmay be used. The annular anchor 800 may be in the form of a tether orother attachment means extending from the coaptation assistance element500 thru the ventricle septum to the right ventricle. The annular anchor800 may be in the form of a tether or other attachment means extendingthru the apex into the epicardium or pericardium. The annular anchor 800may be secured from outside the heart in and combined endo/epiprocedure. When helical anchors are used, they may comprise bio-inertmaterials such as Platinum/Ir, a Nitinol alloy, and/or stainless steel.

In some embodiments, the coaptation assistance element 500 can include asingle central annular anchor 800 inside the annular hub 520. Thecoaptation assistance element 500 can be delivered percutaneously asdescribed herein by attachment of a delivery catheter to the annular hub520. The coaptation assistance element 500 can be configured foradjustable positioning by removing and reattachment of the annularanchor 800. The coaptation assistance element 500 can be recapturable byremoval of the annular anchor 800 and withdrawal of the coaptationassistance element 500. The coaptation assistance element 500, may alsoinclude secondary anchors including commissural anchors, ventricularanchor, annular anchors, barbs, tethers or any other known fixationdevice.

As may be seen in FIGS. 5A-5B, the coaptation assistance element 500 caninclude a plurality of struts 530. In some embodiments, one or more ofthe struts 530 have one end terminating at the hub 520 and the other endextending radially outwardly toward one of the superior edge 540, thelateral edges 570 and 575, and the inferior edge 580 of the coaptationassistance element 500. The struts 530 may extend outward in variousdirections from the hub 520, and can be spaced apart from adjacentstruts 530 at regular or irregular intervals. In some embodiments,adjacent struts 530 extend outward from the hub at an angle of betweenabout 5 degrees and about 45 degrees, between about 10 degrees and about30 degrees, or about 5, 10, 15, 20, 25, or 30 degrees with respect to anadjacent strut 530. The struts 530 may be arranged generally parallel tothe longitudinal axis of the coaptation assistance element 500 to assistin maintaining the shape of the coaptation assistance element 500 uponplacement. The struts 530 may allow the coaptation assistance element500 to assume a reduced configuration for deployment through a catheter.In some embodiments, the struts 530 that form a portion of thecoaptation zone of the implant 500 have a maximum length that is greaterthan struts 530 that only form a portion of the annular zone of theimplant. In some embodiments, the struts 530 that form a portion of thecoaptation zone of the implant can be, for example, at least about 10%,20%, 30%, 40%, 50%, 75%, 100%, 125%, or 150% longer than the struts 530that form a portion of the annular zone of the implant.

FIG. 5A shows a view of the coaptation assistance element 500 with anannular anchor site 535. The annular anchor site 535 can be a portion ofthe struts 530. The annular anchor site 535 is shown extending downwardfrom the coaptation assistance element 500 in FIG. 5A. In otherembodiments, the annular anchor site 535 may extend in other directionsfrom the coaptation assistance element 500 to engage tissue. In someembodiments, the annular anchor site 535 comprises one or more barbshaving a sharpened tip. The annular anchor site 535 may be a passiveanchor.

In some embodiments, the coaptation assistance element 500 can includeone or more retractable barbs. For instance, the barbs can be retractedduring delivery of the coaptation assistance element 500. For instance,the barbs can be advanced after the coaptation assistance element 500 ispositioned relative to the anatomical structures. In some embodiments,the barbs are actively retracted and/or advanced. For instance, thedelivery catheter described herein can include a mechanism coupled tothe barbs designed to retract and/or advance the barbs. In otherembodiments, the barbs are passively advanced and/or retracted. In someembodiments, the coaptation assistance element 500 is delivered with thebarbs in a retracted state. In some embodiments, the barbs can becovered by the valve body covering as described herein. In someembodiments, the interface between the tissue and the valve bodycovering pushes back the valve body covering and exposes the barbs. Insome embodiments, the tissue dissolves and/or absorbs a portion of thevalve body covering and exposes the barbs. In some embodiments, themotion of the purse-string suture, described herein, advances the barbs.In some embodiments, the motion of the purse-string suture causes motionof the valve body covering to expose the barbs. Other configurations arecontemplated.

The annular anchor site 535 may define a diameter D1 shown in FIG. 5B,which may in some embodiments correspond to the distance between themedial and lateral commissures of the native valve or theintracommissural distance (ICD). D1 may range between 20-60 mm with, insome embodiments, a preferred length between 35-45 mm, as correspondingmost closely to the widest range of human mitral ICD. In someembodiments, D1 may be the distance from the right to left fibroustrigones.

The coaptation assistance element 500 can include a generally annularsection 510. The annular section 510 can be positioned above the nativeleaflets when the coaptation assistance element 500 is deployed. In someembodiments, the annular section 510 may be curved toward the annulus orcurved away from the annulus. The annular section 510 can be concave. Inother embodiments, the annular section 510 may be substantially flatwith respect to the annulus. One or more of the struts 530 may curvelaterally from the hub 520 toward the superior edge 540 to assist inmaintaining the shape of the annular section 510 of the coaptationassistance element 500 upon deployment. The coaptation assistanceelement 500 can curve downward from the hub 520 toward the annularanchor site 535. In some embodiments, the coaptation assistance element500 does not rest against the posterior leaflet. In some embodiments,the annular anchor site 535 is the only point of contact between theposterior annulus of the mitral valve and the coaptation assistanceelement 500. The superior edge 540 can include an annular radius ofcurvature. The annular curve radius can curve toward the annulus. Theannular curve radius can curve toward the coaptation surface 560. Insome embodiments, the annular curve radius can be between 0 mm-5 mm, 5mm-10 mm, 10 mm-15 mm, 15 mm-20 mm, 20 mm-25 mm, 25 mm-30 mm, etc.

The struts 530 may be composed of a radio-opaque material. In someembodiments, the struts 530 are composed of resiliently deformablematerials such as a shape memory metal, e.g., Nitinol or a shape memorypolymer. In some embodiments, the material is Elgiloy. In otherembodiments, the struts 530 may be composed of other materials toinclude stainless steel, polypropylene, high density polyethylene (PE),Dacron, acellular collagen matrix such as SIS, or other plastics, etc.In other embodiments, the struts 530 may be a combination such as a highdensity PE sheath around a core of ePTFE, Dacron, and/or polypropylene.The struts 530 may have a circular cross section, an oval cross section,or be ribbon-like. In some embodiments, the struts 530 are coiledsprings or zig-zag shaped. The struts 530 may have a constant stiffness.In some embodiments, one or more struts 530 can have differing stiffnessalong the length of the one or more struts 530. The struts 530 may bestiffer at the annular end than at the ventricular end of the coaptationassistance element 500. The struts 530 may be less stiff at the annularend than at the ventricular end of the coaptation assistance element500. The struts 530 may be stiffer at a midpoint, for instance at aninflection point or curve. The struts 530, along with one or more othersupport structures, can form a frame. In some embodiments, one or moresupport structures may be provided which run parallel to the superioredge 540 of the coaptation assistance element 500 and assist inmaintaining the shape of the superior edge 540. The struts 530 and/orother support structures of the frame can be laser-cut from a Nitinoltube in some embodiments.

The coaptation assistance element body covering 550 may be comprised ofa material such as ePTFE. Other materials for the coaptation assistanceelement body covering 550 include polyester, polyurethane foam,polycarbonate foam, biologic tissue such as porcine pericardium,processed bovine pericardium, pleura, peritoneum, silicone, Dacron,acellular collagen matrix, etc. In some embodiments, the coaptationassistance element body covering 550 can include a foam materialsurrounded by ePTFE. Use of sponge or foam material enhances thecapability of having the coaptation assistance element 500 to fold to asmall enough diameter to pass through a catheter. In some embodiments,the coaptation assistance element body covering 550 has no pores. Inother embodiments, the coaptation assistance element body covering 550may have micropores to enhance endothelialization and cellularattachment. The coaptation assistance element body covering 550 may alsoincorporate a radiopaque material or an echo-enhancement material forbetter visualization. Any support structures of the coaptationassistance element 500 including the struts 530 or support interfaceincluding the hub 520 may be coated with radio-opaque materials such asgold or platinum or impregnated with barium. The coaptation surface 560may be coated with an echo enhancement material. The coaptationassistance element body covering 550 may be coated with a material toinhibit thrombosis, such as heparin bonding or quinoline and quinoxalinecompounds, or with a material to accelerate endothelialization, or withantibiotic to inhibit infection. In some embodiments, the purse-stringsuture 1010 described herein can incorporate a radiopaque material or anecho-enhancement material for better visualization.

In some embodiments, the struts 530 may be sandwiched between layers ofcoaptation assistance element body covering 550. The coaptationassistance element body covering 550 may be composed of the samematerial on the first surface 505 and the second surface 515. Thecoaptation assistance element body covering 550 may be composed ofdifferent materials on the first surface 505, or a portion thereof, andthe second surface 515, or a portion thereof. In some embodiments, thestruts 530 may be attached to or embedded in the first surface 505 orthe second surface 515 of a single layer of coaptation assistanceelement body covering 550. In some embodiments, the struts 530 may be“stitched” through the coaptation assistance element body covering 550.The annular anchor site 535 can be exposed ends of the struts 530 fromthe coaptation assistance element body covering 550.

The coaptation assistance element 500 can include a purse-string suture1010. The purse-string suture 1010 can extend along a portion of thecoaptation assistance element 500. The purse-string suture 1010 canextend along the superior edge 540, or a portion thereof. Thepurse-string suture 1010 can extend along the lateral edge 570, or aportion thereof. The purse-string suture 1010 can extend along thelateral edge 575, or a portion thereof. The purse-string suture 1010 canextend along the inferior edge 580, or a portion thereof. Thepurse-string suture 1010 can extend along a perimeter, or a portionthereof, of the coaptation assistance element 500. The purse-stringsuture 1010 can extend along one or more struts 530. The purse-stringsuture 1010 can extend in a linear path, a non-linear path, a curve, asemi-circle or any open or closed shape.

In some embodiments, the purse-string suture 1010 may be sandwichedbetween layers of valve body covering 550. For instance, thepurse-string suture 1010 can be disposed in a lumen between layers ofcoaptation assistance element body covering 550. In some embodiments,the purse-string suture 1010 may be attached to or embedded in the firstsurface 505 or the second surface 515 of a single layer of valve bodycovering 550. In some embodiments, the purse-string suture 1010 may be“stitched” through the coaptation assistance element body covering 550.The purse-string suture 1010 can pass from the first surface 505 to thesecond surface 515 and back to the first surface 505. The purse-stringsuture 1010 can include one or more exposed ends from the coaptationassistance element body covering 550. In embodiments where thepurse-string suture 1010 is a loop, the purse-string suture can includeone or more exposed sections of the loop from the valve body covering.

The coaptation assistance element 500 may be collapsed by tightening thepurse-string suture 1010. The coaptation assistance element 500 may beexpanded by loosening the purse-string suture 1010. The one or moreexposed ends or loops can be manipulated by a delivery catheter or othertool to tighten or loosen the purse-string suture 1010. The ability tocollapse or expand the coaptation assistance element 500 may bebeneficial for recapture of the coaptation assistance element 500 and/orrepositioning of the coaptation assistance element 500.

The coaptation assistance element 500 may be rotated by tightening oneor more purse-string suture 1010 and/or loosening one or morepurse-string suture 1010. For instance, tightening one or morepurse-string suture 1010 on the lateral edge 570 and/or loosening one ormore purse-string suture 1010 on the lateral edge 575 may cause thecoaptation assistance element 500 to rotate. One or more purse-stringsutures 1010 may be coupled to the coaptation assistance element 500 toenable multi-directional rotation.

The coaptation assistance element 500 may be expanded by loosening thepurse-string suture 1010. The one or more exposed ends or loops can bemanipulated by a delivery catheter or other tool to tighten or loosenthe purse-string suture 1010. The ability to collapse or expand thecoaptation assistance element 500 may be beneficial for recapture of thecoaptation assistance element 500 and/or repositioning of the coaptationassistance element 500.

The coaptation surface 560 of the coaptation assistance element 500 maybe adjusted by motion of the purse-string suture 1010. The one or moreexposed ends or loops can be manipulated by a delivery catheter or othertool to tighten or loosen the purse-string suture 1010 to change thecurvature of the coaptation surface 560 in situ. The ability to adjustthe curvature of the coaptation assistance element 500 may be beneficialto conform to the geometry of heart including the geometry of theanterior leaflet.

The annular dimension of the coaptation assistance element 500 may beadjusted by motion of the purse-string suture 1010. The one or moreexposed ends or loops can be manipulated by a delivery catheter or othertool to tighten or loosen the purse-string suture 1010 to change one ormore dimensions of the coaptation assistance element 500 in situ. Theability to adjust dimensions of the coaptation assistance element 500may be beneficial to conform to the geometry of the heart.

The coaptation assistance element 500 can include one or morepurse-string sutures 1010. In some embodiments, the coaptationassistance element 500 includes one purse-string suture, twopurse-string sutures, three purse-string sutures, four purse-stringsutures, five purse-string sutures, six purse-string suture, sevenpurse-string sutures, eight purse-string sutures, nine purse-stringsutures, ten purse-string sutures, etc. For instance, a purse-stringsuture 1010 can extend along each edge of the coaptation assistanceelement 500. When multiple purse-string sutures are provided, thepurse-string sutures 1010 can act together to change the configurationof the coaptation assistance element 500. When multiple purse-stringsutures are provided, the purse-string sutures 1010 can actindependently to change the configuration of the coaptation assistanceelement 500.

FIG. 5A further illustrates a coaptation element height, correspondingto the distance between the inferior edge 580 and the annular hub 520 asmeasured perpendicular to the plane defined by the annulus of the valve.Coaptation element height of some embodiments may be 10-80 mm, with someembodiments ranging between 40-55 mm. The coaptation element height canbe between 10-20 mm, 20-30 mm, 30-40 mm, 40-50 mm, 50-60 mm, 60-70 mm,70-80 mm, etc.

FIG. 5A illustrates the generally triangular shape of coaptationassistance element 500, such that the coaptation assistance element 500has a superior edge 540, lateral edges 570 and 575, and inferior edge580. In some embodiments, the superior edge 540 has a length greaterthan that of inferior edge 580, such that the transverse distancebetween lateral edges 570 and 575 generally decreases from superior toinferior on the coaptation assistance element 500. For example, thelength of the superior edge 540 may be in the range of 15-50 mm, or25-35 mm, while the length of the inferior edge 580 may be in the rangeof 1-15 mm, or 2-6 mm.

The annular hub 520 may be a hub, an eyelet, or any other tether siteknown in the art. In some embodiments, the annular hub 520 is located ata midpoint of the distance D1. In some embodiments, the annular hub 520is located at a neutral center to prevent swinging of the coaptationassistance element 500 when the coaptation assistance element 500 isheld by the annular hub 520. In other embodiments, the annular hub 520is located at one of the commissures. While only one annular anchor 800is shown, in other embodiments, two or more annular hubs 520 may beprovided.

In some embodiments, the struts 530 can comprise NiTi tubing. In someembodiments, the struts 530 can be laser cut from the tubing. In someembodiments, the frame including one or more struts 530 and/or one ormore support structures can be laser cut from a single piece ofmaterial. In some embodiments, the frame including one or more struts530, the annular hub 520, and/or one or more support structures can beintegrally formed. In some embodiments, the coaptation assistanceelement body covering 550 comprises ePTFE lamination. The lamination cansurround one or more of the struts 530 and/or one or more supportstructures (e.g., one side, two sides, first side 505, second side 515).The struts 530 and/or one or more support structures can be encased bytwo or more layers of lamination. The perimeter of the annular section510 of the coaptation assistance element 500 can be cupped down. Theperimeter of the annular section 510 of the coaptation assistanceelement 500 can be cupped up. The perimeter of the annular section 510of the coaptation assistance element 500 can include secondary anchorssuch as the annular anchor site 535.

In some embodiments, the annular anchor 800 and the annular hub 520 forma single central anchor system. In some embodiments, the coaptationassistance element 500 is affixed to the tissue by only one annularanchor 800 which passes through the hub 520. In other embodiments,additional fixation is included. In some embodiments, the coaptationassistance element 500 is affixed to the tissue by the one anchor 800which passes through the hub 520 and the annular anchor site 535 asdescribed herein. The system can include features to allow rotationaladjustment of the coaptation assistance element 500. For instance, thehub 520 and/or the annular anchor 800 can be coupled to the deliverycatheter to allow the transmission of axial movement and/or torque. Thecoaptation assistance element 500 can be immovably grasped by a deliverycatheter such that rotation of a feature of the delivery catheter, suchas a handle, causes rotation of the coaptation assistance element 500.The coaptation assistance element 500 can be immovably grasped by adelivery catheter such that axial movement of a feature of the deliverycatheter, such as a drive shaft, causes axial movement of the coaptationassistance element 500.

In some embodiments, the hub 520 is located at a neutral position on thecoaptation assistance element 500. The neutral position can be a centrallocation on the annular section 510. The neutral position can be betweenthe lateral edges 505, 515. The neutral position can be between thesuperior edge 540 and the cooptation surface 560. The neutral positioncan enhance stability of the coaptation assistance element 500 when thecoaptation assistance element 500 is grasped at a single location suchas the hub 520 and/or the annular anchor 800. The neutral position canbe aligned with a structure of the mitral valve. The neutral positioncan be aligned along the coaptation zone.

In some embodiments, the coaptation assistance element 500 is deliveredpercutaneously as described herein. In some embodiments, the coaptationassistance element 500 is adjustable via a delivery catheter. Forinstance, the coaptation assistance element 500 can be expanded and/orcollapsed by the delivery catheter. For instance, the coaptationassistance element 500 can be rotated about a fixed position of theannular hub 520. For instance, the coaptation assistance element 500 canbe recapturable. For instance, the coaptation assistance element 500 canbe engaged and reengaged by the delivery catheter. For instance, theannular anchor 800 can be disengaged from the tissue and the deliverycatheter can recapture the coaptation assistance element 500.

FIGS. 5C-5D illustrate embodiments of a frame 565 of the coaptationassistance element 500. These figures illustrated the flattened patternsof the frame 565 prior to bending and/or shape setting. In someembodiments, the frame 565 is cut from a tubular stock. In otherembodiments, the frame 565 is cut from flat stock such as a flat sheetof material. The frame 565 including portions thereof can be laser cut.The frame 565 can include one or more struts 530. In the embodimentshown in FIG. 5D, the frame 565 includes twenty struts 530 but otherconfigurations are contemplated (e.g., one strut, two struts, threestruts, four struts, five struts, between five and ten struts, betweenten and fifteen struts, between fifteen and twenty struts, betweentwenty and twenty-five struts, between twenty-five and thirty struts,between two and thirty struts, between five and thirty struts, etc.). Insome embodiments, the frame 565 can include about, at least about, or nomore than about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or more struts,or a range incorporating any two of the aforementioned values. In someembodiments, the length of the struts extending to the superior upwardlyor downwardly cupping lip are shorter than, such as less than about 80%,70%, 60%, 50%, 40%, 30%, 20%, or less than the longestinferior-extending strut.

In some embodiments, one, two, or more struts 530 are coupled to abacking 585. In some embodiments, the backing 585 is transverse to thedirection of the struts 530. In the illustrated embodiment, the backing585 is vertical or generally vertical and the struts 530 are horizontalor generally horizontal. In some embodiments, the backing 585 is theannular hub 520. For instance, the two ends of the backing 585 can bejoined using methods known in the art to form the annular hub 520. Thetwo ends are joined, for instance, if the frame 565 is cut from flatstock. In other embodiments, the frame 565 is formed from tubular stock.The backing 585 can be a portion of uncut tubular stock. The two ends ofthe backing 585 may not need to be joined if the frame 565 is formedfrom tubular stock. The uncut tubular stock can form the annular hub520. The patters of the frame 565 as shown in FIG. 5D can be cut fromtubular stock, thereby eliminating the need to join the two ends of thebacking. Other modes of manufacturing are contemplated to form the frame565. In other embodiments, the backing 585 forms at least a portion ofthe annular hub 520. In some embodiments, the backing 585 surrounds atleast a portion of the annular hub 520. In some methods ofmanufacturing, the backing 585 can be formed into a shape of a circle.In some methods of manufacturing, the struts 530 extend radially outwardfrom the backing 585 once the backing 585 is shaped into a circle. Thebacking 585 can include one or more openings designed to accept across-pin, as disclosed herein. In some methods of manufacturing, thebacking 585 is removed.

Referring to FIGS. 5A and 5C, a plurality of struts 530 can extend fromthe annular hub 520 to the inferior end 580. In some embodiments, thesestruts 530 are longer than other struts 530 of the frame 565. In someembodiments, the struts 530 might include an anchor or barb thatinteracts with the subvalvular structure, including the ventricularwall. In some embodiments, these struts engage the posterior leaflet oranother anatomical structure. In some embodiments, the ventricularanchoring is passive.

Referring to FIG. 5A-5D, a plurality of struts 530 can extend from theannular hub 520 to the superior end 540. In some embodiments, thesestruts 530 are shorter than other struts 530 of the frame 565. In someembodiments, these struts 530 form an atrial anchor and/or the annularanchor site 535 described herein. In some embodiments, these strutsengage the annulus or another anatomical structure. In some embodiments,the annular anchoring is passive.

Referring to FIGS. 5A and 5D, a plurality of struts 530 can extend fromthe annular hub 520 to the lateral edges 570 and 575. In someembodiments, these struts 530 have a mid-length between the ventricularstruts and the atrial struts. In some embodiments, these struts engagethe commissures or another anatomical structure. In some embodiments,the commissural anchoring is passive.

The struts 530 can have a variety of lengths based on the desired shapeof the coaptation assistance element 500. As shown in FIGS. 5C-5D, twoor more struts 530 have a different length. As shown in FIGS. 5C-5D, twoor more struts 530 have the same length. FIG. 5C shows a schematic modelof the frame 565. One or more of the top three struts can form thecoaptation surface 560 and extend to the inferior edge. One or more ofthe bottom three struts can form the annular portion and extend to thesuperior edge. The struts 530 can be laser-cut from a tube. The lengthcan be measured from the annular hub 520 to an edge of the coaptationassistance element 500. The range of the strut length can be 1 mm to 50mm. The range of the strut length can be 5 mm to 35 mm for the annularportion 510. The strut length can be about 15 mm for the annular portion510. The range of the strut length can be 20 mm to 35 mm for thecoaptation surface 560. The strut length can be about 30 mm for thecoaptation surface 560. Other configurations of the range of strutlength are contemplated e.g., 5 mm to 45 mm, 10 mm to 40 mm, 15 mm to 35mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm,about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about55 mm, about 60 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mmto 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc.

The width can be measured perpendicular to the strut length. The rangeof the strut width can be 0.1 mm to 2 mm. One or more struts can have anouter diameter or width of about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm,0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm,1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, lessthan 1 mm, less than 1.5 mm, less than 2 mm, etc. One or more struts 530can have a varying width along the strut length. In some embodiment, oneor more struts 530 taper near an edge of the coaptation assistanceelement 500. In some embodiments, one or more struts 530 taper near theannular hub 520. The one or more struts 530 can include a reduceddiameter or taper at the connection between the one or more struts 530the annular hub 520. The taper near the annular hub 520 can aid incollapsing the coaptation assistance element 500. The taper near theannular hub 520 can facilitate insertion of the coaptation assistanceelement 500 into the delivery catheter. The taper can reduce stressand/or strain in the strut 530 during collapse. In some embodiments, thetaper can aid in longer fatigue life. In some embodiments, one or morestruts 530 include a varying width taper. The width of the strut 530 canvary along the length of the strut 530. One or more struts 530 caninclude eyelets along the length of the strut 530. In some embodiments,the eyelets can reduce stress of the struts 530. In some embodiments,the eyelets can facilitate adhesion between the strut 530 and the valvebody covering 550.

The thickness can be measured perpendicular to the strut length andstrut width. The thickness can be determined by the thickness of thematerial of the frame, as described herein. The range of the strutthickness can be 0.2 mm to 0.5 mm. One or more struts can have athickness of about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, less than 0.5 mm, less than 1 mm, lessthan 1.5 mm, less than 2 mm, etc.

One or more the struts 530 can include barbs. In some embodiments, thebarbs can be configured for placement near the ventricular end of thecoaptation assistance element 500. In some embodiments, the barbs can bebent out of the plane of the strut 530. In some embodiments, the barbcan have a bayonet configuration. In some embodiments, the barbs canhave a sharped tip. In some embodiments, one or more struts 530 can bebifurcated. In some embodiments, one or more struts 530 can include oneor more zigzag sections. In some embodiments, the zigzag section reducesstress and/or increases flexibility of the strut 530. In someembodiments, the zigzag section facilitates adhesion between the strut530 and the coaptation assistance element body covering 550.

In some embodiments, one or more struts 530 can include supplementalbarbs. In some embodiments, the supplemental barbs can be bent out ofthe plane of the strut 530. In some embodiments, one or more portions ofthe strut length are bent out of the plane of the strut. For instance, aportion of the strut can be twisted or bent during manufacturing. Insome embodiments, the portion that is bent out of plane is shaped toengage tissue. In some embodiments, one or more struts 530 can includeincreased widths to compensate for electropolishing or other postmanufacturing processes. In some embodiments, the backing 585 caninclude one or more features to engage the delivery catheter describedherein. In some embodiments, the backing 585 can include one or morenotches designed to interface with a locking tab or other feature of thedelivery catheter as described herein. In some embodiments, one or morestruts 530 can include a greater width than other struts 530. In someembodiments, the frame 565 includes two or more struts 530 that have agreater width than other struts 530. The two or more struts 530 canfacilitate visualization of the coaptation assistance element 500. Insome embodiments, the two or more struts 530 that have a greater widthare designed to be placed near the commissures when the coaptationassistance element 500 is deployed. In some embodiments, one or morestruts 530 can have smaller width compared with one or more otherstruts. In some embodiments, each strut 530 has the same width near theannular hub 520. The backing 585 can be modified to interface with thedelivery catheter, as described herein. The backing 585 can be designedto allow independent rotation of the anchor 800 within the hub of thecoaptation assistance element 500.

FIGS. 5E, 5F, and 5G show an embodiment of the coaptation assistanceelement 500 without barbs. FIG. 5E shows a schematic perspective view ofthe coaptation assistance element 500. FIG. 5F shows a schematicperspective view of the first surface 505 disposed toward a mal-coaptingnative leaflet. FIG. 5G shows a schematic cross-sectional view includingthe anchor 800.

FIGS. 5H, 5I, and 5J show an embodiment of the coaptation assistanceelement 500 with leaflet anchor sites 545. As shown in FIG. 5A, theannular anchor sites 535 such as barbs can extend along an edge of thecoaptation assistance element 500. FIGS. 5H, 5I, and 5J show anembodiment of the coaptation assistance element 500 with leaflet anchorsites 545 extending from the first surface 505 disposed toward amal-coapting native leaflet.

FIG. 5H shows a schematic perspective view of the coaptation assistanceelement 500 including an enlarged section showing the leaflet anchorsites 545. FIG. 5I shows a schematic perspective view of the firstsurface 505 disposed toward a mal-coapting native leaflet. FIG. 5J showsa schematic cross-sectional view including the anchor 800.

In some embodiments, the leaflet anchor sites 545 comprise one or morebarbs having a sharpened tip. The leaflet anchor sites 545 may be apassive anchor. In some embodiments, the coaptation assistance element500 can include one or more retractable barbs. For instance, the leafletanchor sites 545 can be retracted during delivery of the coaptationassistance element 500. For instance, the leaflet anchor sites 545 canbe advanced after the coaptation assistance element 500 is positionedrelative to the anatomical structures. In some embodiments, the leafletanchor sites 545 are actively retracted and/or advanced. For instance,the delivery catheter described herein can include a mechanism coupledto the leaflet anchor sites 545 designed to retract and/or advance thebarbs. In other embodiments, the leaflet anchor sites 545 are passivelyadvanced and/or retracted. In some embodiments, the leaflet anchor sites545 can be covered by the valve body covering as described herein. Insome embodiments, the interface between the tissue and the valve bodycovering pushes back the valve body covering and exposes the leafletanchor sites 545. In some embodiments, the tissue dissolves and/orabsorbs a portion of the valve body covering and exposes the leafletanchor sites 545. In some embodiments, the motion of the purse-stringsuture, described herein, advances the leaflet anchor sites 545. In someembodiments, the motion of the purse-string suture causes motion of thevalve body covering to expose the leaflet anchor sites 545. Otherconfigurations are contemplated.

One or more struts 530 may have one or more barbs along the length ofthe strut 530. In the illustrated embodiment, five struts 530 each havefour leaflet anchor sites 545 along the length of the struts. Otherconfigurations are contemplated varying the number of struts 530 (e.g.,one strut, two struts, three struts, four struts, five struts, sixstruts, seven struts, eight struts, nine struts, ten struts, etc.) andvarying the number of leaflet anchor sites 545 per strut 530 (e.g., onebarb, two barbs, three barbs, four barbs, five barbs, six barbs, sevenbarbs, eight barbs, nine barbs, ten barbs, etc.). One or more struts 530can have the same number of leaflet anchor sites 545. Two or more struts530 can have a different number of leaflet anchor sites 545. The leafletanchor sites 545 can be disposed to engage the posterior leaflet.

In some embodiments, the struts 530 may be sandwiched between layers ofvalve body covering 550. In some embodiments, the struts 530 may beattached to or embedded in the first surface 505 or the second surface515 of a single layer of valve body covering 550. In some embodiments,the struts 530 may be “stitched” through the valve body covering 550.The first surface 505 can include one or more openings for the leafletanchor sites 545. In other embodiments, the leaflet anchor sites 545 canpush through the valve body covering 550. The leaflet anchor sites 545can have a pre-set curve which can exert a force on the first surface505. The leaflet anchor sites 545 can be sharpened to cut through thevalve body covering 550.

The frame 565 can have many advantages. The frame 565 can be formed froma flattened pattern. The frame 565 can include an edge which forms theannular hub 520. The edge can include a longitudinal strip or backing585. One or more struts 530 can extend from the backing 585. In theillustrated embodiment of FIGS. 5C and 5D, the one or more struts 530are perpendicular to the longitudinal strip. The struts 530 aregenerally parallel. In some embodiments, the struts 530 are generallyperpendicular to the backing 585 that forms the annular hub 520. In someembodiments, the struts 530 form an angle with the backing 585. Forinstance, the longitudinal axis of the struts 530 can form an acuteangle with the backing 585. The angle can aid in the collapse of thestruts 530 into the delivery catheter.

The frame 565 can be constructed from a single, planar sheet ofmaterial. The frame 565 can be precisely cut using water jet, laseretching or similar technology. The details of the struts 530, includingbarbs, can be machined into the struts 530. The frame 565 can be bentand/or shape set to achieve the desired geometry. In some embodiments,the backing 585 is folded to form a loop. The frame 565 can be rolledinto a tubular shape. The backing 585 can be welded or otherwisesecured. The backing 565 when secured end to end to form a loop can beconsidered the annular hub 520.

The struts 530 are bent to the desired configuration. The struts 530 canform one or more curves. The struts 530 can have one or more inflectionpoints. The struts 530 can have concave portions and/or convex portions.One or more struts 530 can include a radially outward flare beginning atan inflection point. In some embodiments, the superior edge 540 iscurved upward away from the inferior edge 580. In some embodiments, thesuperior edge 540 is curved downward toward the inferior edge 580. Insome embodiments, one or more struts 530 can be substantially flat. Thestruts 530 near the commissures can be substantially flat. In someembodiments, the inferior edge 580 is curved backward toward thesuperior edge 540. In some embodiments, the inferior edge 580 is curvedforward away from the superior edge 540.

The struts 530 can be equally spaced about the circumference of theannular hub 520. The struts 530 can be unequally spaced about thecircumference of the annular hub 520. The struts 530 extending along aportion of the circumference of the annular hub 520 are different thanstruts extending along another portion of the circumference of theannular hub 520. One or more designated portions of the struts 530 canbe designed to be placed near the annular region of the heart. One ormore designated portions of the struts 530 can be designed to be placednear the commissure region of the heart. One or more designated portionsof the struts 530 can be designed to be placed near the ventricularregion of the heart. The geometry of the radially extending struts 530can be shaped to match the geometry of the patient. In some embodiments,the geometry is patient specific. The operator can shape one or morestruts 530 based on the geometry of the heart. The operator can modifythe shape of one or more struts 530 based on the geometry of thepatient.

FIG. 5K illustrates dimensions of the coaptation assistance element 500.The coaptation assistance element 500 can include a dimension A. Thedimension A can be a linear projected dimension or posterior projection.In some embodiments, the range of dimension A can be 1 mm to 40 mm. Insome embodiments, the range of dimension A can be 4 mm to 24 mm. Otherconfigurations of the range of dimension A are contemplated e.g., 5 mmto 35 mm, 10 mm to 30 mm, 15 mm to 25 mm, about 1 mm, about 2 mm, about3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about9 mm, about 10 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mmto 25 mm, 20 mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. Thedimension A can be 0 mm if no posterior projection, for instance if thecoaptation assistance element 500 is straight.

The coaptation assistance element 500 can include a dimension B. In someembodiments, the dimension B can be a radius of curvature. The radius ofcurvature can be concave or convex, as described herein. In someembodiments, the range of dimension B can be 1/16 inch to ½ inch. Insome embodiments, the range of dimension B can be 1.5 mm to 13 mm. Insome embodiments, the range of dimension B can be ¼ inch to ⅜ inch. Insome embodiments, the range of dimension B can be 6 mm to 9.5 mm. Insome embodiments, the range of dimension B can be 1 mm to 15 mm. Otherconfigurations of the range of dimension B are contemplated e.g., 2 mmto 14 mm, 3 mm to 13 mm, 4 mm to 12 mm, 5 mm to 11 mm, 6 mm to 10 mm, 7mm to 9 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm,about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, 1 mm to 10mm, 5 mm to 15 mm, 10 mm to 20 mm, etc. The dimension B can be 0 mm ifno curvature, for instance if the coaptation assistance element 500 isstraight.

The coaptation assistance element 500 can include a dimension C. In someembodiments, the dimension C can be a radius of curvature near thesuperior edge 540. In some embodiments, the range of dimension C can be1 mm to 10 mm. In some embodiments, the range of dimension C can be 1 mmto 5 mm. Other configurations of the range of dimension C arecontemplated e.g., 2 mm to 9 mm, 3 mm to 8 mm, 4 mm to 7 mm, 5 mm to 6mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, 1 mm to 15 mm, 5 mmto 10 mm, 3 mm to 9 mm, etc. The dimension C can be 0 mm if nocurvature, for instance if the coaptation assistance element 500 isstraight.

The coaptation assistance element 500 can include a dimension D. Thedimension D can be a coaptation element height. The dimension D cancorrespond to the distance between the inferior edge 580 and the atrialanchor site or annular hub 520 as measured perpendicular to the planedefined by the annulus of the valve. In some embodiments, the range ofdimension D can be 10 mm to 80 mm. In some embodiments, the range ofdimension D can be 40 mm to 55 mm. Other configurations of the range ofdimension D are contemplated e.g., 5 mm to 105 mm, 10 mm to 100 mm, 15mm to 95 mm, 20 mm to 90 mm, 25 mm to 85 mm, 30 mm to 80 mm, 35 mm to 75mm, 40 mm to 70 mm, 45 mm to 65 mm, 50 mm to 60 mm, about 10 mm, about20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm,about 80 mm, about 90 mm, about 100 mm, 10 mm to 50 mm, 20 mm to 60 mm,30 mm to 70 mm, 40 mm to 80 mm, 50 mm to 90 mm, 60 mm to 100 mm, 70 mmto 110 mm, etc.

The coaptation assistance element 500 can include a dimension E. Thedimension E can be a linear projected dimension or anterior projection.In some embodiments, the range of dimension E can be 2 mm to 20 mm. Insome embodiments, the range of dimension E can be 5 mm to 10 mm. Otherconfigurations of the range of dimension E are contemplated e.g., 0 mmto 25 mm, 5 mm to 20 mm, 10 mm to 15 mm, about 1 mm, about 2 mm, about 3mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm,about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about20 mm, 1 mm to 10 mm, 5 mm to 15 mm, 10 mm to 20 mm, 15 mm to 25 mm, 20mm to 30 mm, 25 mm to 35 mm, 30 mm to 40 mm, etc. The dimension E can be0 mm if no anterior projection.

The struts 530 of the coaptation assistance element 500 can form aposterior curve of the coaptation surface 560. The posterior bend canhave a bend length of the distal 30-100% of the strut. In someembodiments, the posterior bend can have a bend length of at least thedistal 40% of the strut. The angle of the posterior bend can be in therange of 0 degrees to 90 degrees with respect to the longitudinal axisof the coaptation assistance element 500. In some embodiments, the angleof the posterior bend can be in the range 45 degrees to 90 degrees.

FIG. 6 illustrates an embodiment of a coaptation assistance element 600.The coaptation assistance element 600 can be similar to the coaptationassistance element 500, and include any features of the coaptationassistance element 500 described herein, with certain additionalfeatures described below.

The coaptation assistance element 600 can include an annular hub 620engaging an annular anchor (not shown). The annular hub 620 may have abuilt-in or coupled annular anchor, such as annular anchor 800 describedherein. The annular anchor may include a helix rotatable with respect tothe annular hub 620. In some embodiments, the coaptation assistanceelement 600 can include a single annular anchor inside the annular hub620. The coaptation assistance element 600 can be deliveredpercutaneously as described herein by attachment of a delivery catheterto the annular hub 620.

As may be seen in FIG. 6 , the coaptation assistance element 600 caninclude struts 630. In some embodiments, one, two, or more struts 630have one end terminating at the annular hub 620 and the other endextending radially outwardly toward the superior edge 640, the lateraledges 670 and 675, and the inferior edge 680 of the coaptationassistance element 600. The struts 630 may extend outward from the hub620. The struts 630 may be arranged generally parallel to thelongitudinal axis of the coaptation assistance element 600 to assist inmaintaining the shape of the coaptation assistance element 600 uponplacement. The struts 630 may allow the coaptation assistance element600 to assume a reduced configuration for deployment through a catheter.

The coaptation assistance element 600 can include an annular section610. The annular section 610 can be positioned above the annulus of thenative leaflet when the coaptation assistance element 600 is deployedand form a lip as shown. In some embodiments, the annular section 610may be may be curved upwardly, e.g., away from the annulus and in adirection substantially opposite from, and substantially parallel to thecoaptation surface 660, and form the superior-most portion of thecoaptation assist element 600 when implanted. The annular section 610can be convex. In other embodiments, the annular section 610 may be maybe substantially flat with respect to the annulus. One or more of thestruts 630 may curve laterally from the annular hub 620 toward thesuperior edge 640 to assist in maintaining the shape of the annularsection 610 of the coaptation assistance element 600 upon deployment.The coaptation assistance element 600 can curve upward from the annularhub 620. In some embodiments, the superior edge 640 does not restagainst the posterior leaflet. The superior edge 640 can include anannular radius of curvature. The annular curve radius can curve awayfrom the annulus. The annular curve radius can curve toward thecoaptation surface 660. In some embodiments, the annular curve radiuscan be between 0 mm-5 mm, 5 mm-10 mm, 10 mm-15 mm, 15 mm-20 mm, 20 mm-25mm, 25 mm-30 mm, etc., or ranges incorporating any two of the previousvalues. The coaptation assistance element body covering 650 may besimilar to the coaptation assistance element body covering 550 describedherein.

In some embodiments, the perimeter of the annular section 610 is cuppedupward and in a direction substantially opposite to the longitudinalaxis of the coaptation surface 660. In some embodiments, the coaptationassistance element 600 includes annular anchor site similar to annularanchor site 535. In other embodiments, the coaptation assistance element600 does not include annular anchor site as shown in FIG. 6 .

FIGS. 7A-7E illustrate an embodiment of a coaptation assistance element700. The coaptation assistance element 700 can be similar to thecoaptation assistance elements 500 or 600, and can include any featuredescribed herein, with certain elements described below.

The coaptation assistance element 700 can include a first surface 705and a second surface 715. FIG. 7A illustrates a perspective view of thefirst surface 705 or inferior surface disposed toward a mal-coaptingnative leaflet, in the instance of a mitral valve, the posteriorleaflet. FIG. 7B illustrates a perspective view of the second surface715 or superior surface which may be disposed toward the anteriorleaflet. The second surface 715 can include a coaptation surface 760.The superior edge 740 of the coaptation assistance element 700 may becurved to match the general shape of the annulus or adjoining atrialwall. The superior edge 740 can be curved downward, toward the posteriorleaflet, as shown in FIG. 7B. FIG. 7C illustrates a top view of thecoaptation assistance element 700.

FIGS. 7A-7C show a view of the coaptation assistance element 700 with anannular hub 720. The coaptation assistance element 700 can include theannular hub 720 designed to engage the annular anchor 800. The annularanchor 800 may be engaged at a proximal end by a driver, describedherein. The annular hub 720 may have a built-in or coupled annularanchor 800. The annular anchor 800 may comprise a helix rotatable withrespect to the annular hub 720. The coaptation assistance element 700can be delivered percutaneously as described herein by attachment of adelivery catheter to the annular hub 720.

As may be seen in FIGS. 7A-7C, the coaptation assistance element 700 caninclude struts 730. In some embodiments, one or more struts 730 have oneend terminating at the annular hub 720 and the other end extendingradially outwardly toward the superior edge 740, the lateral edges 770and 775, and the inferior edge 780 of the coaptation assistance element700 shown in FIG. 7B. The annular anchor site 735 is shown extendingdownward from the body of the coaptation assistance element 700 in FIG.7B. The annular anchor 800 can be an active anchor. The annular anchorsites 735 can be a passive anchor, such as barbs. The annular anchorsites 735 can be at the distal ends of one or more struts 730.

The annular section 710 can be positioned above the native leaflets whenthe coaptation assistance element 700 is deployed. In some embodiments,the annular section 710 may be may be curved toward the annulus oratrial wall. One or more of the struts 730 may curve laterally from thehub 720 toward the superior edge 740 to assist in maintaining the shapeof the annular section 710 of the coaptation assistance element 700 upondeployment. The coaptation assistance element 700 can curve downwardfrom the annular hub 720 toward the annular anchor site 735. The annularsection 710 can be concave. In some embodiments, one or more supportstructures may be provided which run parallel to the superior edge 740of the coaptation assistance element 700 and assist in maintaining theshape of the superior edge 740. The struts 730 and/or other supportstructures of the frame can be laser-cut from a Nitinol tube in someembodiments. The valve body covering 750 may be comprised of a materialas described herein.

In some embodiments, the coaptation assistance element 700 includes anactive anchor such as annular anchor 800. In some embodiments, thecoaptation assistance element 700 includes a passive anchor such asannular anchor site 735. The annular anchor site 735 can include barbsat the tip of one or more struts 730.

The coaptation assistance element 700, as well as any coaptationassistance element 500, 600 described herein, can include one or moremarkers 900. The marker 900 can be positioned on any portion of thecoaptation assistance element 500, 600, 700 or any element thereof, suchas the struts 530, 630, 730, the annular hub 520, 620, 720, thepurse-string suture 1010, and/or the annular anchor sites 535, 735. Insome embodiments, the marker 900 is positioned on the annular anchor800. In other embodiments, the marker 900 is integrally formed with thecoaptation assistance element 500, 600, 700 or the annular anchor 800. Aplurality of markers 900 can be arranged in specific patterns, on thecoaptation assistance element, to provide a fluoroscopic visual aid forthe operator to accurately orient and position the coaptation assistanceelement 500, 600, 700 and/or the annular anchor 800 within the heart ofa patient.

In some embodiments, the markers 900 may be radio-opaque or they may becovered by a radio graphic marker. During the process of delivery of thecoaptation assistance element 500, 600, 700 and/or the annular anchor800, the markers 900 may be visualized if a fluoroscope is used. Themarker 900 can help position the coaptation assistance element 500, 600,700 and/or the annular anchor 800 within the heart of a patient. In someembodiments, torque can be applied to the annular anchor 800 such thatthe annular anchor 800 is driven into the tissue. To provide feedbackwhether the annular anchor 800 is secured appropriately, fluoroscopicmarkers 900 may be present on the annular anchor 800. The markers may belocated at the proximal end. These markers 900 may inform the medicalteam about how far the annular anchor 800 may have travelled towards theannular hub 520, 620, 720 and may be informative about when the annularanchor 800 is securely in place. In some embodiments, to ensure thatappropriate torque is applied, the torque level at a handle may spike asthe annular anchor 800 bottoms out on the annular hub 520, 620, 720. Thesystems described herein can include one or more markers 900 (e.g., one,two, three, four, five, six, seven, eight, nine, ten, more than one,more than two, more than three, more than four, etc.). The systemsdescribed herein can include two or more different markers 900. Thedifferent markers can indicate different components of the system,different portions of the coaptation assistance element 500, 600, 700 orpositioning points such as the most proximal point, most distal point,midline, etc.

FIGS. 7D-7E illustrate an embodiment of the coaptation assistanceelement 700 deployed within the heart mitral valve model. Referring backto FIG. 1F, the coaptation zone CL between the leaflets is not a simpleline, but rather a curved funnel-shaped surface interface as shown inFIG. 7C. The first 110 (Anterio-lateral or left) and second 114(Posterio-medial or right) commissures are where the anterior leaflet 12meets the posterior leaflet at the coaptation zone, which form thecoaptation line (CL). As seen most clearly in the axial views from theatrium of FIG. 7D, an axial cross-section of the coaptation zonegenerally shows the curved line CL that is separated from a centroid ofthe annulus as well as from the opening through the valve duringdiastole. In addition, the leaflet edges are scalloped, more so for theposterior versus the anterior leaflet. Mal-coaptation can occur betweenone or more of these A-P (anterior-posterior) segment pairs A1/P1,A2/P2, and A3/P3, so that mal-coaptation characteristics may vary alongthe curve of the coaptation zone CL, as shown in FIG. 1F.

In some embodiments, the coaptation assistance element 700 is placedover the posterior leaflet to create a new surface onto which the nativeleaflet, here the anterior leaflet, can coapt. The mitral valve is shownwith the anterior leaflet 12. The zone of coaptation occurs between theanterior leaflet 12 and the coaptation surface 760 of the coaptationassistance element 700.

Referring now to FIG. 8A, aspects of the delivery catheter 1000 areillustrated. The delivery catheter 1000 can include a control handle.The delivery catheter 1000 can include a tip deflection control 1001.The tip deflection control 1001 can allow a distal portion of thedelivery catheter 1000 to deflect. This may be advantageous to place thecoaptation assistance element 500, 600, 700 within the mitral valve. Thedelivery catheter 1000 can be inserted into a transseptal sheath (notshown). The transseptal sheath allows the introduction of the deliverycatheter into the left atrium. The delivery catheter 1000 may furtherinclude one or more ports 1002, such as a flush, irrigation and/oraspiration port to remove the air from the system and allow injection offluids such as saline or contrast media to the site of implantation. Thecatheter 1000 can include a catheter shaft 1006. The catheter 1000 caninclude an implant inserter 1007.

The delivery catheter 1000 may include an implant control knob 1003. Theimplant control knob 1003 can control the movements of the coaptationassistance element 500, 600, 700. The implant control knob 1003 mayenable the collapse of the coaptation assistance element 500, 600, 700.The implant control knob 1003 may enable the expansion of the coaptationassistance element 500, 600, 700. The arrow 1003 a indicates thedirection of movement of the implant control knob 1003 for thecoaptation assistance element 500, 600, 700 to be collapsed by thedelivery catheter 1000 and/or expanded by the delivery catheter 1000.The implant control knob 1003 may enable the rotation of the coaptationassistance element 500, 600, 700. The arrow 1003 b indicates thedirection of movement of the implant control knob 1003 for thecoaptation assistance element 500, 600, 700 to be rotated.

The implant control knob 1003 can be internally connected to thecoaptation assistance element 500, 600, 700 to allow the transmission ofaxial movement and/or torque. For instance, the implant control knob1003 of the delivery catheter 1000 can be coupled to the annular hub520, 620, 720 For instance, the implant control knob 1003 can beconnected to one or more purse-string suture 1010 which may control thedeployment of the coaptation assistance element 500, 600, 700. Thepurse-string suture 1010 may facilitate the collapse and/or expansion ofthe coaptation assistance element 500, 600, 700 as described herein. Thepurse-string suture 1010 may facilitate the rotation of the coaptationassistance element 500, 600, 700 as described herein. In someembodiments, the delivery catheter 1000 releasably engages coaptationassistance element 500, 600, 700 such that axial movement and torque canbe transmitted from the delivery catheter 1000 to the coaptationassistance element 500, 600, 700

In some embodiments, a tip 1300 of the delivery catheter 1000 isreleasably coupled to the annular hub 520, 620, 720 For instance, thetip 1300 of the delivery catheter 1000 can lock onto the annular hub520, 620, 720 such that movement of the delivery catheter 1000 causesmovement of the coaptation assistance element 500, 600, 700. In someembodiments, the system includes a release mechanism between thedelivery catheter 1000 and the annular hub 520, 620, 720.

The annular hub 520, 620, 720 may have features, which can lock with thetip 1300 of the delivery catheter 1000. Referring back to FIGS. 5A-7E,the annular hub 520, 620, 720 can include one or more features to engagea portion of the delivery catheter 1000. The feature can include one ormore notches in the hub 520 of the Implant as shown in FIG. 5A. Thefeature can include an internal lip as shown in FIG. 9A. The feature caninclude windows accessible from the outside of the hub 520, 620, 720, asshown in FIG. 8C. The feature can include any structure or mechanismcapable of coupling the annular hub 520, 620, 720 and a portion of thedelivery catheter 1000. In some embodiments, the annular hub 520, 620,720 and the delivery catheter 1000 are coupled via a screw mechanism.For instance, the annular hub 520, 620, 720 can include a female threadand the distal end of the delivery catheter 1000 can include a malethread. In some embodiments, the annular hub 520, 620, 720 and thedelivery catheter 1000 are coupled via a noose and pin configuration.For instance, the annular hub 520, 620, 720 can include a pin such as anoutwardly extending pin and the distal end of the delivery catheter 1000can include a loop or noose designed to be tightened around the pin.Other configurations are contemplated.

FIG. 8B shows the coaptation assistance element 500, 600, 700 coupled tothe delivery catheter 1000. The coaptation assistance element 500, 600,700 can be collapsed as shown or expanded as shown by the dashed linesby movement along arrow 1003 a. The coaptation assistance element 500,600, 700 can be rotated as shown by the dashed lines by movement alongarrow 1003 b.

Referring to FIG. 8C, the delivery catheter 1000 can include the tip1300. The distal end of the tip 1300 can include distal locking tabs. Insome embodiments, the tip 1300 includes a plurality of pre-bent orshape-set locking tabs. In some embodiments, the tip includes twolocking tabs, three locking tabs, four locking tabs, five locking tabs,a plurality of locking tabs, a multitude of locking tabs, etc. This“AT-lock” (axial-torsional lock) can include nitinol locking tabs on thetip 1300. In some embodiments, the locking tabs of the tip 1300 can beactuated by a sheath 1350. In some embodiments, the sheath 1350 ishollow to allow movement of other components such as the driverdescribed herein. The movement sheath 1350 can force the locking tabsinward into engagement with the annular hub 520, 620, 720. In someembodiments, the locking tabs of the tip 1300 engage a feature such as awindow or lip of the annular hub 520, 620, 720. In some embodiments,movement of the sheath 1350 in the opposite direction can cause therelease of the annular hub 520, 620, 720 from the tip. In otherembodiments, the locking tabs of the tip 1300 can be actuated by acentral pin inserted within tip 1300 (not shown). In some embodiments,the central pin is hollow to allow movement of other components such asthe driver described herein. The movement of the central pin can forcethe locking tabs outward into engagement with the annular hub 520, 620,720.

In some embodiments, the distal end of the tip 1300 can be actuated tolock the delivery catheter 1000 to the annular hub 520, 620, 720. Insome embodiments, the distal end of the tip 1300 can be actuated tounlock the delivery catheter 1000 from the annular hub 520, 620, 720. Asdescribed herein, secondary structures such as the purse-string suturesmay remain coupled to the coaptation assistance element 500, 600, 700after the annular hub 520, 620, 720 is released from the tip 1300. Insome embodiments, when the delivery catheter 1000 is unlocked, one ormore secondary structures such as the purse-string sutures describedherein can retain a relative position between the delivery catheter 1000and the annular hub 520, 620, 720. During a procedure, the tip 1300 maybe repeatedly locked and unlocked.

Referring back to FIG. 8A, the delivery catheter 1000 can include theanchor control knob 1004. In some embodiments, the anchor control knob1004 can enable the release of the annular anchor 800 and/or thecoaptation assistance element 500, 600, 700. In some embodiments, theanchor control knob 1004 can enable the engagement of the annular anchor800 for instance to rotate the annular anchor 800 and/or to axially movethe annular anchor 800. In some embodiments, the anchor control knob1004 can enable the disengagement of the annular anchor 800. In someembodiments, the anchor control knob 1004 can control a driver 1200configured to apply torque. In some embodiments, the anchor control knob1004 can control a driver 1200 configured to apply tension and/orrelease the coaptation assistance element 500, 600, 700. In someembodiments, the anchor control knob 1004 can control a driver 1200configured to apply tension and torque.

The anchor control knob 1004 of the delivery catheter 1000 may becoupled to the annular anchor 800 to allow transmission of torque to theannular anchor 800. The anchor control knob 1004 may enable simplemanipulation of the torque or position of the annular anchor 800. Thearrow 1004 a indicates the direction of movement of the anchor controlknob 1004 for the annular anchor 800 to be engaged or disengaged. Forinstance, moving the anchor control knob 1004 toward the annular anchor800 may engage a driver 1200 with the annular anchor 800. The arrow 1004b indicates the direction of movement of the anchor control knob 1004for the transmission of torque to the annular anchor 800. In someembodiments, the arrow 1004 b indicates the direction to release theannular anchor 800. For instance, the further application of torque maytwist the driver 1200 out of engagement with the annular anchor 800.

An embodiment of an annular anchor 800 is illustrated in detail in FIG.9A. Other components of the delivery catheter 1000 are not shown in FIG.9A, such as the component which engages the annular hub 520, 620, 720.The annular anchor 800 may be coupled to the driver 1200 in variousways, as described herein. The annular anchor 800 may be coupled to thecoaptation assistance element 500, 600, 700 in various ways. In someembodiments, the annular hub 520, 620, 720 may have a cross-pin 820. Thecross-pin 820 can provide a site about which a helical structure 815 ofthe annular anchor 800 may wrap around as shown. The annular anchor 800can have a shoulder 805. The shoulder 805 may fit around the outside ofa driver 1200 of the delivery catheter 1000.

In some embodiments, the driver 1200 is releasably coupled to theannular anchor 800. The driver 1200 can be coupled and/or controlled bythe anchor control knob 1004 described herein. One or more drivers 1200can deliver torque to drive the annular anchor 800 into tissue. One ormore drivers 1200 can deliver tension to hold and/or release the annularanchor 800. In some embodiments, a single driver 1200 delivers torqueand tension. In other embodiments, two or more drivers 1200 delivertorque and tension. For instance, the driver 1200 can lock onto theannular anchor 800 such that movement of the driver 1200 causes movementof the annular anchor 800. In some embodiments, the system includes arelease mechanism between the driver 1200 and the annular anchor 800. Insome embodiments, the distal end of the driver 1200 can be actuated tolock the driver 1200 to the annular anchor 800. In some embodiments, thedistal end of the driver 1200 can be actuated to unlock the driver 1200from the annular anchor 800. In some embodiments, when the driver 1200is unlocked, one or more secondary structures such as the purse-stringsutures can retain a relative position between the delivery catheter1000 and the annular anchor 800. During a procedure, the driver 1200 maybe repeatedly locked and unlocked.

FIG. 9B illustrates an embodiment of a driver 1200. The driver 1200 caninclude a torque shaft 1205. The torque shaft 1205 can include a loop1210. The loop 1210 can engage a pin 1215 extending and looping aroundthe tension cross-pin 1270 and through the anchor 800. The rotation ofthe torque shaft 1205 can cause a torque to be applied to a torquecross-pin 1275, thereby causing rotation of the annular anchor 800. Insome embodiments, the annular anchor 800 can include a torque cross-pinand a tension cross-pin. Another driver (not shown) can apply a torqueto the tension cross-pin to apply tension to the annular anchor 800. Oneor more drivers 1200 can engage the annular anchor 800 to delivertorque. One or more drivers 1200 can engage the annular anchor 800 todeliver tension. In some embodiments, delivery of the annular anchor 800is independent of rotation of the coaptation assistance element 500,600, 700.

FIG. 9C illustrates an embodiment of a driver 1200. The driver 1200 caninclude a torque shaft 1220. The torque shaft 1220 can include an anchordocking cap 1225. The anchor docking cap 1225 can engage the annularanchor 800 in a single orientation or one of a plurality oforientations. In some embodiments, the annular anchor 800 includes aprotrusion 1230 and the anchor docking cap 1225 is designed to acceptthe protrusion 1230. In other embodiments, the annular anchor 800includes a recess (not shown) to accept a mating protrusion on theanchor docking cap 1225 (not shown). The rotation of the torque shaft1220 can cause a torque to be applied to the annular anchor 800. Anotherdriver 1235 can apply tension to the annular anchor 800. In someembodiments, the driver 1235 can include a release screw. In otherembodiments, the loop and pin release mechanism described in FIG. 9B maybe used. The release screw can be rotated to release the annular anchor800. One or more drivers 1200 can engage the annular anchor 800 todeliver torque. One or more drivers 1200 can engage the annular anchor800 to deliver tension.

FIG. 9D illustrates an embodiment of a driver 1200 and the annularanchor 800. The driver 1200 can include a torque shaft 1220. The torqueshaft 1220 can include an anchor docking cap 1225. In some embodiments,the annular anchor 800 includes a protrusion 1230 and the anchor dockingcap 1225 is designed to accept the protrusion 1230. In otherembodiments, the annular anchor 800 includes a recess (not shown) toaccept a mating protrusion on the anchor docking cap 1225 (not shown).Two or more wires 1240, 1245 can apply tension to the annular anchor800. In some embodiments, the wire 1240 acts as a pin, and the wire 1245terminates in a ball. In a retained state, the wires 1240, 1245 are bothpositioned within an opening in the annular anchor 800. The opening istoo small to allow the pin and ball end of wires 1240, 1245 to pass sideby side. In some methods of use, the wire 1240 is retracted first. Theretraction of the wire 1240 yields sufficient room to allow retractionof the wire 1245. The wires 1240, 1245 can be actuated to release theannular anchor 800. One or more drivers 1200 can engage the annularanchor 800 to deliver torque. One or more drivers 1200 can engage theannular anchor 800 to deliver tension

FIG. 9E illustrates an embodiment of the driver 1200. The driver 1200can include a torque shaft 1255. The shoulder 805 may have features suchas windows 810 which can lock with one or more distal locking tabs 1265of the torque shaft 1255. The distal locking tabs 1265 may includenitinol material such as a Shape-set NiTi clip. The distal locking tabs1265 may be pushed outward into the windows 810 by a driver 1260. Thedriver 1260 acts as a release mechanism. The longitudinal movement ofthe driver 1260 toward the annular anchor 800 may push the distallocking tabs 1265 outward toward the windows 810. The longitudinalmovement of the driver 1260 away from the annular anchor 800 may allowthe distal locking tabs 1265 to regain a neutral configuration anddisengage from the windows 810. The distal locking tabs 1265 engagedwith the windows 810 of the annular anchor 800 can allow thetransmission of axial movement between the torque shaft 1255 and theannular anchor 800. The distal locking tabs 1265 engaged with thewindows 810 of the annular anchor 800 can allow the transmission oftorque between the torque shaft 1255 and the annular anchor 800. Inembodiments where the annular anchor 800 is built-in or captured by theannular hub 520, 620, 720, the distal locking tabs 1265 engaged with thewindows 810 can allow the transmission of axial movement between thedelivery catheter and the coaptation assistance element 500, 600, 700.

In some embodiments, an advantage is the annular anchor 800 can berotated independently of the coaptation assistance element 500, 600,700. As described herein, the coaptation assistance element 500, 600,700 is coupled to the delivery catheter 1000. As described herein, theannular anchor 800 is independently coupled to the driver 1200. Theannular anchor 800 can be rotated independently of the annular hub 520,620, 720. The annular hub 520, 620, 720 can remain stationary as theannular anchor 800 is rotated to engage tissue.

In some methods, the annular anchor 800 can be preloaded onto thecoaptation assistance element 500, 600, 700 and coupled to the driver1200 during the process of mounting the coaptation assistance element500, 600, 700 onto the delivery catheter 1000. This can occur before thecoaptation assistance element 500, 600, 700 is pulled into an implantsheath and/or another portion of the delivery catheter 1000 and is beingreadied for insertion into the femoral vein. As disclosed herein, torquecan be applied such that the annular anchor 800 is driven into thetissue. In some embodiments, to ensure that appropriate torque isapplied, the torque level at the handle may spike as the annular anchor800 bottoms out on the annular hub 520, 620, 720. This increased torquelevel may be felt at the handle providing feedback that appropriatetorque has been applied. In other embodiments, radiopaque markings mayaid in visually determining the level of anchor engagement withintissue. In some embodiments, the markings can be located on the annularanchor 800 and/or the coaptation assistance element 500, 600, 700.

FIGS. 10-15 show various methods, which may be performed during a methodof use of the coaptation assistance element 500, 600, 700. The methodmay include collapsing the coaptation assistance element 500, 600, 700.The method may include of coupling the coaptation assistance element500, 600, 700 to the delivery catheter 1000. The method may includecoupling the locking tabs 1265 with the annular anchor 800 and/or thecoaptation assistance element 500, 600, 700. The method can include anystep disclosed herein for manufacturing the coaptation assistanceelement 500, 600, 700.

In some embodiments, an advantage is the coaptation assistance element500, 600, 700 can be delivered with a hub-leading orientation. In thismethod of use, the annular hub 520, 620, 720 can be moved into positionrelative to the anatomical structures prior to another portion of thecoaptation assistance element 500, 600, 700. In some methods of use, theventricular end of the coaptation assistance element 500, 600, 700 canbe retained within the delivery catheter 1000 until the annular hub 520,620, 720 is positioned. In some methods of use, once the annular hub520, 620, 720 and/or the annular anchor 800 are engaged with the tissue,the coaptation assistance element 500, 600, 700 can be expanded. In somemethods of use, once the annular hub 520, 620, 720 and/or the annularanchor 800 are engaged with the tissue, the ventricular end of thecoaptation assistance element 500, 600, 700 can be positioned.

In some embodiments, an advantage is the coaptation assistance element500, 600, 700 can be delivered with a strut-leading orientation. In thismethod of use, one or more of the struts 530, 630, 730 of the coaptationassistance element 500, 600, 700 can be moved into position relative tothe anatomical structures prior to another portion of the coaptationassistance element 500, 600, 700. In some methods of use, the coaptationassistance element 500, 600, 700 can be expanded or partially expandedprior to the positioning of the annular hub 520, 620, 720. In somemethods of use, the annular hub 520, 620, 720 can be retained within thedelivery catheter until one or more of the struts 530, 630, 730 arepositioned. In some methods of use, once the struts 530, 630, 730 arepositioned, the annular anchor 800 is engaged with the tissue.

FIG. 10 illustrates an embodiment of transseptal crossing. The methodmay include femoral vein access. Access may be gained through a vesselsuch as the femoral vein in order to reach a chamber of the heart suchas the right atrium 1300. The left ventricle 1380 and its papillarymuscles are also shown 1360. The method may include transseptal punctureand crossing with standard transseptal kit 1330 to the left atrium 1320.The method may include exchanging for custom transseptal sheath anddelivery catheter 1000, as described herein. A transseptal puncture kitmay be exchanged for a transseptal sheath and dilator, and the dilatormay be exchanged for an implant delivery catheter which may be asdisclosed herein and in U.S. Pat. No. 8,888,843 to Khairkhahan et al.,incorporated by reference in its entirety. The method may includeremoving a dilator. The method may include advancing the deliverycatheter 1000. However, other approaches such as transapical,transatrial, femoral artery, brachial artery, and the like are alsowithin the scope of the invention.

FIG. 11 illustrates initial advancement of the coaptation assistanceelement 500, 600, 700. The method may include advancing the coaptationassistance element 500, 600, 700 inside the retrieval sheath. Theretrieval sheath can include a tip having a plurality of petalsradiating from a central hub 1420. The retrieval sheath may bepositioned within a transseptal sheath 1400. The mitral valve is show atthe base of the left atrium 1440. The method may include advancing theannular section 510, 610, 710 toward the annulus before advancing thecoaptation surface 560, 660, 760 toward the annulus. The method mayinclude deploying the ventricular end or inferior surface 580 afterdeploying the annular portion 510.

FIG. 12 illustrates partial deployment of the coaptation assistanceelement 500, 600, 700. The coaptation assistance element 500, 600, 700may be advanced in proximity to the target location under imagingguidance such as ultrasound or fluoroscopy. The annular anchor 800coupled with the coaptation assistance element 500, 600, 700 is engagedin tissue. An anchor torque shaft 1540 may be rotated internally andindependent of the rotation of an implant torque shaft (not shown).Controlled release of a purse-string suture 1010 around the perimeter ofthe coaptation assistance element 500, 600, 700 may cause the coaptationassistance element 500, 600, 700 to expand. Prior to full expansion ofthe coaptation assistance element 500, 600, 700, rotational adjustmentof the coaptation assistance element 500, 600, 700 may be performed toalign the interior (ventricular) section of the coaptation assistanceelement 500, 600, 700 with a valve opening 1580.

The method may include advancing the coaptation assistance element 500,600, 700 toward a target location. The method may include advancing theannular hub 520, 620, 720 toward a target location. The method mayinclude advancing the annular anchor 800, which is coupled to theannular hub 520, 620, 720, toward a target location. The method mayinclude echo or fluoroscopic guidance of the annular anchor 800, the hub520, 620, 720, and/or the coaptation assistance element 500, 600, 700.The method may include engaging the annular anchor 800 in tissue. Themethod may include rotating the anchor control knob 1004 to rotate theannular anchor 800. The method may include the independent rotation ofthe annular anchor 800 from the hub 520, 620, 720. The method mayinclude holding the hub 520, 620, 720 stationary during rotation of theannular anchor 800. The method may include controlled release of thepurse-string suture 1010. The release may cause the coaptationassistance element 500, 600, 700 to expand. The purse-string suture 1010may be disposed within the coaptation assistance element 500, 600, 700and/or along a perimeter of the coaptation assistance element 500, 600,700. The purse-string suture 1010 can facilitate the collapse and/orexpansion of the coaptation assistance element 500, 600, 700. The methodmay include rotational adjustment of the coaptation assistance element500, 600, 700 to align an inferior edge 580, 680, 780 or ventricularsection of the coaptation assistance element 500, 600, 700 with thevalve opening. The method may include rotational adjustment of thecoaptation assistance element 500, 600, 700 to align an inferior edge580, 680, 780 or ventricular section around the posterior leaflet.

FIG. 13 illustrates recapture of the coaptation assistance element 500,600, 700. The coaptation assistance element 500, 600, 700 may berecaptured by tightening a purse-string suture 1010 around a portion ofthe perimeter 1620 of the coaptation assistance element 500, 600, 700 tocollapse the coaptation assistance element 500, 600, 700. The perimetercan include any edge, any combination of edges, or all of the edgesdescribed herein. A recapture sheath and transseptal sheath 1600 may beadvanced over the collapsed coaptation assistance element 500, 600, 700.Recapture sheath petals that radiate from a central hub may roll overthe coaptation assistance element 500, 600, 700 allowing the coaptationassistance element 500, 600, 700 to be retracted into the transseptalsheath. The annular anchor 800 may be unscrewed or otherwise released,and the system may be removed. The prolapsed or partially encapsulatedcoaptation assistance element 500, 600, 700 by the recapture sheathpetals can be another mode of delivery. The encapsulated-first deliverymode can be in contrast to the hub-first and the strut-delivery modesdescribed herein.

In some methods, recapture is an optional method. The method may includetightening of the purse-string suture 1010. This tightening may collapsethe coaptation assistance element 500, 600, 700. The method may includeadvancing the recapture sheath and/or the transseptal sheath over thecollapsed coaptation assistance element 500, 600, 700. The recapturesheath can fold outward to roll over the coaptation assistance element500, 600, 700. The method may include retracting the coaptationassistance element 500, 600, 700 into the transseptal sheath. The methodmay include rotating the annular anchor 800 to disengage tissue. Themethod may include removing the coaptation assistance element 500, 600,700 and the annular anchor 800.

FIG. 14 illustrates a cross-section view of the deployed coaptationassistance element 500, 600, 700. The method may include releasing ofthe coaptation assistance element 500, 600, 700. The method may includeretraction of the delivery catheter 1000.

FIG. 15 illustrates deployment of secondary anchors. In some methods,deployment of secondary anchors is an optional method. The method mayinclude engaging annular attachment sites 535, 735 to the annulus. Themethod may include engaging ventricular anchors. The method may includeengaging commissural anchors 1650. The method may include deployingmarkers on strategic locations on the coaptation assistance element 500,600, 700 and/or the annular anchor 800. The method may include detectingmarkers, such as detecting radiopaque markers. The method may includefacilitating the placement of anchor 800 under fluoroscopy. The methodmay include locating radiopaque markers along the perimeter of thecoaptation assistance element 500, 600, 700 to indicate the shape ofcoaptation assistance element 500, 600, 700.

In some embodiments, the manufacturer provides instructions for use ofthe system including one or more of the steps disclose herein, or anystep previously described or inherent in the drawings.

FIGS. 16-30 show various methods, which may be performed during a methodof use of the coaptation assistance element 500, 600, 700. The methodcan include any step disclosed herein, according to some embodiments ofthe invention. The method can include any step disclosed herein formanufacturing and/or deploying the coaptation assistance element 500,600, 700. The method can include collapsing the coaptation assistanceelement 500, 600, 700.

FIG. 16 illustrates a method for implant delivery showing loading of thecoaptation assistance element 500, 600, 700. The coaptation assistanceelement 500, 600, 700 can be collapsed, as described herein. Thecollapsed coaptation assistance element 500, 600, 700 can be loaded intoa transseptal sheath introducer 1700. The transseptal sheath introducer1700 can include a sheath having a lumen to accommodate the collapsedcoaptation assistance element 500, 600, 700. The collapsed coaptationassistance element 500, 600, 700 can be inverted within the transseptalsheath introducer 1700. The annular hub 520, 620, 720 can be positionednear the edge 1705 of the transseptal sheath introducer 1700. Thetransseptal sheath introducer 1700 can include a multilumen catheter1710 connected to the coaptation assistance element 500, 600, 700. Themethod can include loading of the coaptation assistance element 500,600, 700 into the transseptal sheath introducer 1700.

FIG. 17 illustrates a method for inserting the transseptal sheathintroducer 1700 into a transseptal sheath 1715. The transseptal sheathintroducer 1700 can include the multilumen catheter 1710. The multilumencatheter 1710 and/or the transseptal sheath introducer 1700 can includea hub 1720. The hub 1720 can connect with the transseptal sheath 1715.The proximal end of the transseptal sheath 1715 is shown in FIG. 17 . InFIG. 17 , the transseptal sheath introducer 1700 is not connected to thetransseptal sheath 1715. In FIG. 18 , the transseptal sheath introducer1700 is connected to the transseptal sheath 1715. The method can includeconnecting the transseptal sheath introducer 1700 to the transseptalsheath 1715. The method can include connecting an assembly comprisingthe coaptation assistance element 500, 600, 700 to the transseptalsheath 1715.

FIG. 19 illustrates a method for advancing the transseptal sheathintroducer 1700. The transseptal sheath introducer 1700 can be advancedto the distal end of the transseptal sheath 1715. The coaptationassistance element 500, 600, 700 can be advanced through the transseptalsheath 1715. The collapsed coaptation assistance element 500, 600, 700can be inverted while advancing through the transseptal sheath 1715. InFIG. 19 , the coaptation assistance element 500, 600, 700 is at thedistal end of the transseptal sheath 1715.

FIG. 20 illustrates a method for positioning the transseptal sheath1715. The coaptation assistance element 500, 600, 700 can be located atthe distal end of the transseptal sheath 1715 during positioning. Thetransseptal sheath 1715 can be positioned in the annulus. Thetransseptal sheath 1715 can be positioned over the posterior leaflet.The transseptal sheath 1715 can be centered over P2 described herein.The method can include locating the coaptation assistance element 500,600, 700 to the posterior leaflet. The method can include locating thecoaptation assistance element 500, 600, 700 centered over P2. The methodcan include locating the coaptation assistance element 500, 600, 700 inthe annulus. The transseptal sheath 1715 can be rotated as shown by thearrows. The transseptal sheath 1715 can position the coaptationassistance element 500, 600, 700 by rotating. The transseptal sheath1715 can correct atrial/ventricle orientation. The transseptal sheath1715 can include one or more markings/indicia 1725. The markings 1725can enable a user to guide the rotation of the transseptal sheath 1715.The markings 1725 can enable a user to provide correct orientation of anannulus portion of the coaptation assistance element 500, 600, 700. Themarkings 1725 can enable a user to provide correct orientation of aventricle portion of the coaptation assistance element 500, 600, 700. Insome embodiments, the marking 1725 can include a radiopaque marker. FIG.20 shows the coaptation assistance element 500, 600, 700 and thetransseptal sheath 1715 centered over P2 in the annulus of a mitralvalve. FIG. 20 shows rotation of the coaptation assistance element 500,600, 700 and the transseptal sheath 1715.

FIG. 21 illustrates a method for delivering the anchor 800. The anchor800 can include any of the features of the anchors described herein. Theanchor 800 can be considered a P2 anchor based on the location of theanchor 800 after deployment. The anchor 800 can extend through theannular hub 520, 620, 720 as described herein. The method can includedelivering in the anchor 800 while the coaptation assistance element500, 600, 700 is within the transseptal sheath 1715. In someembodiments, the anchor 800 is coupled to the annular hub 520, 620, 720of the coaptation assistance element 500, 600, 700 before loading intothe transseptal sheath 1715. In some embodiments, the anchor 800 iscoupled to the annular hub 520, 620, 720 of the coaptation assistanceelement 500, 600, 700 while within the transseptal sheath 1715. In someembodiments, the anchor 800 is coupled to the annular hub 520, 620, 720of the coaptation assistance element 500, 600, 700 after the transseptalsheath 1715 is positioned within the annulus. The method can includedelivering the anchor 800 while the coaptation assistance element 500,600, 700 is within the transseptal sheath 1715. The coaptationassistance element 500, 600, 700 can be centered over P2 in the annulusduring delivery of the anchor 800. The anchor 800 can be inserted byrotating the anchor 800 into the tissue of the annulus, as describedherein.

FIGS. 22A-22D illustrate a method for deploying the coaptationassistance element 500, 600, 700. The coaptation assistance element 500,600, 700 can be deployed by retracting the transseptal sheath 1715. Thetransseptal sheath 1715 can be retracted by moving the transseptalsheath 1715 proximally from the anchor 800. The coaptation assistanceelement 500, 600, 700 can be inverted within the transseptal sheath1715. In some embodiments, the annular portion near the annular hub 520,620, 70 of the coaptation assistance element 500, 600, 700 can bedeployed first as shown in FIG. 22A. In some embodiments, theventricular portion of the coaptation assistance element 500, 600, 700can be deployed next as shown in FIG. 22B. The coaptation assistanceelement 500, 600, 700 can be inverted such that the ventricular portionextends proximally from the annular portion. In some embodiments, thecoaptation assistance element 500, 600, 700 can expand outward from P2as the coaptation assistance element 500, 600, 700 is deployed as shownin FIG. 22C. The coaptation assistance element 500, 600, 700 can beinverted such that the ventricular portion extends proximally from theannular portion. The coaptation assistance element 500, 600, 700 can beinverted such that the ventricular portion extends toward thetransseptal sheath 1715.

In some embodiments, the coaptation assistance element 500, 600, 700 canbe folded back as shown in FIG. 22D. The coaptation assistance element500, 600, 700 can be reversed from the initially deployed configurationsuch that the ventricular portion extends distally from the annularportion. The coaptation assistance element 500, 600, 700 can bepositioned such that the ventricular portion extends away from thetransseptal sheath 1715. The method can include deploying the coaptationassistance element 500, 600, 700 by retracting the transseptal sheath1715. FIGS. 22A-22D show deployment of the coaptation assistance element500, 600, 700.

FIGS. 23-30 illustrate deploying one or more secondary anchors 850. Thesecondary anchor 850 can include any of the features of the anchor 800.The secondary anchor 850 can comprise a helix or helical structure. Thesecondary anchor 850 can be designed to engage the tissue of heart, suchas the tissue of the annulus. The secondary anchor 850 can comprisebio-inert materials such as Platinum/Ir, a Nitinol alloy, and/orstainless steel.

FIG. 23 illustrates a method for utilizing one or more secondary anchorguidewires. The coaptation assistance element 500, 600, 700 can includeone or more secondary anchor guidewires. In the illustrated embodiment,the coaptation assistance element 500, 600, 700 can include the firstguidewire 1730 and the second guidewire 1735. In some embodiments, thecoaptation assistance element 500, 600, 700 can include any number ofsecondary anchor guidewires (e.g., about or at least about one, two,three, four, five, etc.). In some embodiments, the number of secondaryanchor guidewires corresponds to (equals) the number of secondaryanchors (e.g., one guidewire for one secondary anchor, two guidewiresfor two secondary anchors, etc.). FIG. 23 illustrates an embodiment of adocking tube 1740. The docking tube 1740 can include any of the featuresdescribed herein, including those shown in FIGS. 42A-45K.

FIG. 23 illustrates a tether mode. The tether mode can correspond to oneor more methods to evaluate the coaptation assistance element 500, 600,700. The tether mode can correspond to one or more methods to evaluatethe function of the coaptation assistance element 500, 600, 700 withoutone or more delivery systems. In some embodiments, the tether mode cancorrespond to one or more methods to evaluate the function of thecoaptation assistance element 500, 600, 700 without the transseptalsheath 1715. The tether mode can evaluate function without the bulk ofthe delivery system attached. FIG. 23 shows the deployed coaptationassistance element 500, 600, 700. FIG. 23 shows the coaptationassistance element 500, 600, 700 going to tether mode by retracting animplant shaft. FIG. 23 shows the coaptation assistance element 500, 600,700 going to tether mode by retracting the transseptal sheath 1715.

FIG. 24 illustrates a method involving the docking tube 1740. Thedocking tube 1740 can include internal threads. The docking tube 1740can include an internally threaded DS hub for coupling to an externallythreaded portion 525, 625, 725 of the annular hub 520, 620, 720. Thedocking tube 1740 can include an internally threaded hub for coupling tothe coaptation assistance element 500, 600, 700. In some methods of use,the docking tube 1740 is removed for tether mode. FIG. 24 shows thecoaptation assistance element 500, 600, 700 going to tether mode byretracting the docking tube 1740.

FIG. 24 illustrates a method involving an anchor driver 1745. The anchordriver 1745 can be disposed within the docking tube 1740. The anchordriver 1745 can include any of the features described herein, includingthose shown in FIGS. 42A-45K. The anchor driver 1745 can rotate theanchor 800 during the method shown in FIG. 21 . The anchor driver 1745can rotate the anchor 800 through the annular hub 520, 620, 720. In somemethods of use, the anchor driver 1745 is removed for tether mode. FIG.24 shows the coaptation assistance element 500, 600, 700 going to tethermode by retracting the anchor driver 1745.

The anchor driver 1745 can include a tether rail 1750. The tether rail1750 can include any of the features described herein, including thoseshown in FIGS. 42A-45K. The tether rail 1750 can be secured to theanchor 800. The tether rail 1750 can allow for a minimal forceevaluation of the effective of the coaptation assistance element 500,600, 700 prior to releasing the coaptation assistance element 500, 600,700. As one example, the user can verify that the coaptation assistanceelement 500, 600, 700 is functional. As one example, the user can verifythat the native leaflet is coapting against the coaptation assistanceelement 500, 600, 700. As one example, the user can verify that theforce exerted on the coaptation assistance element 500, 600, 700 iswithin an acceptable range. As one example, the user can verify that thecoaptation assistance element 500, 600, 700 is not deforming under theforce of the native leaflet. As one example, the user can verify thatthe coaptation assistance element 500, 600, 700 is deployed. As oneexample, the user can verify that the coaptation assistance element 500,600, 700 spans the mitral valve. The docking tube 1740 can be retractedas shown. As shown in FIG. 24 , the tether rail 1750 can remain coupledto the anchor 800 during tether mode.

FIG. 25 illustrates a method for advancing secondary anchor guiderails.In the illustrated embodiment, the method can include the firstguiderail 1755 and the second guidewire 1760. In some embodiments, thecoaptation assistance element 500, 600, 700 can include any number ofsecondary anchor guiderails (e.g., one, two, three, four, five, etc.).In some embodiments, the number of secondary anchor guiderailscorresponds to the number of secondary guidewires (e.g., one guiderailfor one secondary guidewire, two guiderails for two secondaryguidewires, etc.). The first guiderail 1755 can be advance along thefirst guidewire 1730. The second guiderail 1760 can be advanced alongthe second guidewire 1735. The method can involve advancing bothsecondary anchor guiderails 1755, 1760. The secondary anchor guiderails1755, 1760 are over the guidewires 1730, 1735 in FIG. 25 .

The distal end 1765 of each secondary anchor guiderail 1755, 1760 can bethreaded. In some embodiments, the distal end 1765 of each secondaryanchor guiderail 1755, 1760 engages tissue in the annulus. The distalend 1765 can be threaded to temporarily secure the secondary anchor tothe guiderail 1755, 1760 during delivery. In some embodiments, thedistal end 1765 of each secondary anchor guiderail 1755, 1760 can reducethe likelihood that the secondary anchor inadvertently comes off thesecondary anchor guiderail 1755, 1760. The secondary anchor guiderails1755, 1760 can reduce the likelihood that the secondary anchors gettangled with the guide wires 1730, 1735. In some embodiments, thediameter of the secondary anchor guiderails 1755, 1760 is greater thanor equal to the secondary anchor pitch.

In some methods of use, the docking tube 1740 can be coupled to thecoaptation assistance element 500, 600, 700. The attachment can allowfor recess of the anchor 800 during delivery of the coaptationassistance element 500, 600, 700. In some embodiments, the secondaryanchor guiderails 1755, 1760 are advanced over guidewires 1730, 1735prior to deploying the anchor 800. In some embodiments, the secondaryanchor guiderails 1755, 1760 are advanced over guidewires 1730, 1735after deploying the anchor 800. FIG. 25 shows the coaptation assistanceelement 500, 600, 700 secured to the annulus with the anchor 800 withsecondary anchor guiderails advanced to the surface of the coaptationassistance element 500, 600, 700.

FIG. 26 illustrates a method for delivering a secondary anchor 1770. Thesecondary anchor 1770 is advanced over the first guiderail 1755. Thesecondary anchor 1770 can be advanced toward the coaptation assistanceelement 500, 600, 700. The secondary anchor 1770 can be installed with adriver 1775. The driver 1775 can translate the secondary anchor 1770along the first guiderail 1755.

FIG. 27 illustrates a method for inserting the secondary anchor 1770.The driver 1775 can rotate the secondary anchor 1770 along the firstguiderail 1755. The secondary anchor 1770 can be threaded through thecoaptation assistance element 500, 600, 700. The secondary anchor 1770can be rotated to engage tissue underneath the coaptation assistanceelement 500, 600, 700. FIG. 26 shows the coaptation assistance element500, 600, 700 secured to the annulus with the anchor 800 when thesecondary anchor 1770 is delivered. FIG. 26 shows the coaptationassistance element 500, 600, 700 secured to the annulus with the anchor800 when the secondary anchor 1770 is inserted into tissue. The driver1775 is still attached as shown in FIG. 27 The secondary anchor 1770 canbe a medial anchor. The secondary anchor 1770 can be positioned on amedial side of the anchor 800.

FIG. 28 illustrates a method for delivering a secondary anchor 1780. Thesecondary anchor 1780 is advanced over the second guiderail 1760. Thesecondary anchor 1780 can be advanced toward the coaptation assistanceelement 500, 600, 700. In some methods of use, the secondary anchor 1780can be installed with a driver 1775. In some methods of use, the driver1775 can be retracted along the first guide rail 1755 prior to beingadvanced along the second guiderail 1760. In other methods of use, thesecondary anchor 1780 is installed with a different driver than thesecondary anchor 1770. The driver 1775 can translate the secondaryanchor 1780 along the first guiderail 1760. In some methods of use, thesecondary anchor 1770 can be previously inserted into the tissue.

The driver 1775 can rotate the secondary anchor 1780 along the secondguiderail 1760. The secondary anchor 1780 can be threaded through thecoaptation assistance element 500, 600, 700. The secondary anchor 1780can be rotated to engage tissue underneath the coaptation assistanceelement 500, 600, 700. FIG. 28 shows the coaptation assistance element500, 600, 700 secured to the annulus with the anchor 800 and thesecondary anchor 1770 when the secondary anchor 1780 is delivered. FIG.26 shows the coaptation assistance element 500, 600, 700 secured to theannulus with the anchor 800 and the secondary anchor 1770 when thesecondary anchor 1780 is inserted into tissue. The secondary anchor 1780can be a lateral anchor. The secondary anchor 1780 can be positioned ona lateral side of the anchor 800.

FIG. 29 illustrates the coaptation assistance element 500, 600, 700 withsecondary anchor guidewires 1730, 1735. The tether rail 1750 can remaincoupled to the anchor 800. The secondary anchor guidewires 1730, 1735remain connected. The delivery system can be re-attached. In somemethods of use, one or more guiderails 1755, 1760 can be re-attached. Insome methods of use, the driver 1775 is re-attached. One or moresecondary anchors 1770, 1780 can be removed. One or more secondaryanchors 1770, 1780 can be repositioned. In some methods of use, thedocking tube 1740 can be re-attached. In some methods of use, the anchordriver 1745 can be re-attached. The anchor 800 can be removed. Theanchor 800 can be repositioned. The anchor 800 and the secondary anchors1770, 1780 can be removed. The coaptation assistance element 500, 600,700 can be retrieved. FIG. 29 shows the deployed and anchored coaptationassistance element 500, 600, 700 with the secondary anchor guidewires1730, 1735 and the tether rail 1750 remaining, allowing for retrieval.

FIG. 30 illustrates the anchored coaptation assistance element 500, 600,700. The secondary anchor guidewires 1730, 1735 are removed. The tetherrail 1750 is removed. In some embodiments, the tether rail 1750 isrotated and retracted. The coaptation assistance element 500, 600, 700is shown completely deployed and anchored. In some methods of use,retrieval is no longer possible. In some methods of use, retrievalthrough the method described in FIGS. 31A-31F is no longer possible.

FIGS. 31A-31F illustrate methods for retrieving the coaptationassistance element 500, 600, 700. The coaptation assistance element 500,600, 700 can be retrieved through the transseptal sheath 1715. In somemethods of use, without secondary anchors 1770, 1780, the coaptationassistance element 500, 600, 700 can be retrieved after the anchor 800is removed. In some methods of use, the coaptation assistance element500, 600, 700 can be retrieved after the anchor 800 and all thesecondary anchors 1770, 1780 are removed. The coaptation assistanceelement 500, 600, 700 is being retrieved through the transseptal sheath1715 in FIGS. 31A-31F. In some methods of use, the retrieval isoptional. In some methods of use, the retrieval occurs after the methodshown in FIG. 29 and before the method shown in FIG. 30 .

FIGS. 32-35 illustrate a method for installing one or more secondaryanchors. One or more methods can be used in conjunction with methodsdescribed herein. One or more methods can be as an alternative tomethods described herein. As one example, one or more methods shown inFIGS. 32-35 can replace one or more methods shown in FIGS. 23-30 . Thesecondary anchors described herein can be delivered using guidewiresand/or guiderails with a variety of designs. In some embodiments, eachsecondary anchor can have a dedicated lumen (e.g., two secondary anchorsuse two lumens; four secondary anchors use four lumens, etc.). In someembodiments, each secondary anchor can have a dedicated guidewire (e.g.,two secondary anchors use two guidewires, four secondary anchor use fourguidewires, etc.). In some embodiments, two secondary anchors share alumen (e.g., two secondary anchors in one lumen, four secondary anchorsin two lumens; two guidewires in one lumen, four guidewires in twolumens, etc.) In some embodiments, each of the two guidewires in theshared lumen is covered by a guiderail. The guiderail can reducesecondary anchor entanglement. The guiderail can reduce secondary anchorentanglement with the two or more guidewires in the lumen.

FIG. 32 illustrates a method for inserting a secondary anchor. In somemethods of use, the secondary anchor 1770 is inserted as describedherein. The guidewire 1735 can extend from the secondary anchor 1770.The guidewire 1735 can extend into a lumen or a shared lumen. In somemethods of use, the secondary anchor 1770 is inserted as describedherein. One or more secondary anchors 1170, 1780 can be inserted.

In some embodiments, one guidewire 1735 can be used for two secondaryanchors. In some methods of sue, to facilitate removal of the guidewire1735 after delivery of the first secondary anchor 1770, the guidewire1735 can be snared and removed. In some embodiments, the guidewire 1735forms a loop. In some embodiments, a portion of the loop of theguidewire 1735 is contained within the coaptation assistance element500, 600, 700. In some embodiments, the loop threads through thecoaptation assistance element 500, 600, 700. In some embodiments, asnare 1785 can be positioned along the guidewire 1735. In someembodiments, the snare 1785 forms a loop. In some embodiments, a portionof the loop of the guidewire 1735 is contained within loop of the snare1785. The method can include using the snare 1785. The snare 1785 can befor unthreading the guidewire 1735. The snare 1785 can be retracted. Thesnare 1785 can be pulled proximally through a lumen.

FIG. 33 illustrates a method for delivering a secondary anchor 1790. Thesnare 1785 has been retracted within the lumen. The snare 1785 haspulled the guidewire 1735 proximally. In some embodiments, the driver1775 or another driver can advance the secondary anchor 1790 along theguidewire 1735. In some embodiments the secondary anchor 1790 is to bedelivered with the guidewire 1735 removed using the snare 1785 from theanchor 1770.

FIG. 34 illustrates a method for inserting the secondary anchor 1790.The secondary anchor 1790 can be rotated. The secondary anchor 1790 canbe threaded through the coaptation assistance element 500, 600, 700. Thesecondary anchor 1790 can be rotated to engage tissue underneath thecoaptation assistance element 500, 600, 700. FIG. 34 shows thecoaptation assistance element 500, 600, 700 secured to the annulus withthe anchor 800 and the secondary anchor 1770 when the secondary anchor1790 is delivered. The secondary anchor 1790 can be a medial anchor. Thesecondary anchor 1790 can be positioned on a medial side of the anchor800. The secondary anchor 1790 can be positioned between the anchor 800and the secondary anchor 1770.

FIG. 35 illustrates the anchored coaptation assistance element 500, 600,700. The methods can be repeated to install one or more additionalsecondary anchors. For instance, one or more additional secondaryanchors can be positioned between the secondary anchor 1780 and theanchor 800 as shown in FIG. 30 . For instance, one or more additionalsecondary anchors can be positioned between the secondary anchor 1770and the anchor 800 as shown in FIG. 30 . For instance, one or moreadditional secondary anchors can be positioned anywhere on the annularportion of the coaptation assistance element 500, 600, 700.

FIGS. 36 and 37 illustrates embodiments of 2D lamination. FIGS. 38 and39 illustrate embodiments of 3D forming. In some embodiments, thecoaptation assistance element 500, 600, 700 comprises a multi-layerlaminate on the entire, or only a portion of the coaptation assistanceelement. In some embodiments, the multi-layer laminate can comprise twoor more layers of laminate (e.g., two, three, four, five, etc.). Two ormore layers of the multi-layer laminate can comprise the same material.Two or more layers of the multi-layer laminate can comprise differentmaterials. Two or more layers of the multi-layer laminate can comprisethe same dimensions (e.g., length, width, thickness, diameter, etc.).Two or more layers of the multi-layer laminate can comprise one or moredifferent dimensions. The laminate can be variable, depending on thezone of the coaptation assistance element 500, 600, 700. In someembodiments, the cooptation zone can have additional protective layers.In some embodiments, the coaptation surface 560, 660, 760 includes oneor more additional layers than another portion of the coaptationassistance element 500, 600, 700. FIG. 38 shows the additional layer1795 only in the coaptation zone (e.g., inferior zone) of the coaptationassistance element 500, 600, 700. As such the inferior coaptation zonecan be thicker than that of the superior zone of the coaptationassistance element residing proximate the heart valve annulus, such atleast about 10%, 25%, 50%, 75%, 100%, 150%, 200%, 250%, 300%, or morethicker than that of the superior zone, or ranges incorporating any twoof the aforementioned values.

The multi-layer laminate can be fabricated in 2D lamination methods. Insome methods of use, two or more layers are bonded together. The layerscan be bonded by heat. The layers can be bonded by adhesive. The layerscan be bonded together through any mechanical or chemical change. Thecoaptation assistance element 500, 600, 700 can have a generally 2Dshape. The coaptation assistance element 500, 600, 700 can be flat orgenerally flat. In some embodiments, one or more layers comprise highdensity polyethylene (PE), polypropylene Dacron, acellular collagenmatrix such as SIS, or other plastics.

The multi-layer laminate can be fabricated in 3D shape forming methods.The coaptation assistance element 500, 600, 700 can be shaped. Asdescribed herein, the coaptation assistance element 500, 600, 700 cancomprise struts 530, 630, 730. In some embodiments, the struts 530, 630,730 are composed of resiliently deformable materials such as a shapememory metal, e.g., Nitinol or a shape memory polymer. In someembodiments, the material is Elgiloy. In some embodiments, the struts530 may be composed of other materials to include stainless steel,polypropylene, high density polyethylene (PE), Dacron, acellularcollagen matrix such as SIS, or other plastics, etc. The 3D forming caninvolve molding the shape of the struts 530, 630, 730. The 3D formingcan include adjusting the shape memory metal into the appropriate shape.The shape can be set with appropriate molds which bend the struts 530,630, 730 into the desired shape. Shape setting or shape training mayinclude constraining the coaptation assistance element 500, 600, 700 ona fixture or within a mold. In some methods of use, an appropriate heattreatment is applied to the coaptation assistance element 500, 600, 700while on the fixture or within the mold. In some embodiments, thetemperature, time and/or other parameters are adjusted to heat set thecoaptation assistance element 500, 600, 700. In some embodiments, thetemperature for heat setting is greater than 300° C., greater than 400°C., greater than 500° C., greater than 600° C., etc. In someembodiments, the time for heat setting is 1 minute, 2 minutes, 3minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9minutes, 10 minutes, more than 2 minutes, more than 5 minutes, more than10 minutes, etc. In some embodiments, the method can include rapidcooling. In some embodiments, the method can include rapid cooling viawater or air.

FIG. 40 illustrates a coaptation assistance element 400. The coaptationassistance element 400 can include any of the features of the coaptationassistance elements described herein. The coaptation assistance element400 can include an annular hub 420 to facilitate attachment to adelivery system, similar to the annular hubs described herein. Theannular hub 425 can include an externally threaded portion 425. Thecoaptation assistance element 400 can include struts 430. The struts 430can be atrial arms that may be bend in the superior and/or inferiordirection.

The coaptation assistance element 400 can include an annular anchor site435. The annular anchor site 435 can be a portion of the struts 430. Insome embodiments, the annular anchor site 435 comprises one or morebarbs having a sharpened tip. The annular anchor site 435 can be apassive anchor. The barbs can be exposed fully and shaped as shown inFIG. 40 . In some embodiments, the barbs extend from the multi-layerlaminate. The barbs can be the free ends of the struts 430. In someembodiments, the barbs can lay on the surface of the coaptationassistance element 400. In some embodiments, the barbs can engage tissuewith push-back of laminate. For instance, the multi-layer laminate canbe pushed back as shown in FIG. 41 . FIG. 41 illustrates an embodimentof a barb. In some methods of use, engagement of the barb with tissuemay cause the multi-layer laminate to push back.

The coaptation assistance element 400 can include a knotless suturededge 455. The edge may reduce trauma to the native tissue. Thecoaptation assistance element 400 can include one or more rounded edgesthat reduce trauma. In some embodiment, the lateral edges of thecoaptation assistance element 400 are rounded. In some embodiment, thesuperior edge of the coaptation assistance element 400 is rounded. Insome embodiment, the inferior edge of the coaptation assistance element400 is rounded.

The coaptation assistance element 400 can include a coaptation surface460. The coaptation surface 460 can include additional protectivelayers. In some embodiments, the coaptation surface 460 can include oneor more additional layers of the multi-layer laminate. In someembodiments, the coaptation surface 460 can include one or moredifferent layers of the multi-layer laminate. The one or more layers ofthe coaptation surface 460 can be designed to facilitate longevity ofthe coaptation assistance element 400. The one or more layers of thecoaptation surface 460 can be designed to facilitate coaptation with thenative leaflet.

FIGS. 42A-45K illustrate embodiments of implant delivery systems. Theimplant delivery systems can include any coaptation assistance elementdescribed herein. The implant delivery systems can be designed toposition the coaptation assistance element within the heart. The implantdelivery systems can include any anchor described herein. The implantdelivery systems can be designed to engage the anchor with tissue. Theimplant delivery systems can be designed to rotate the anchor.

FIGS. 42A-42 i illustrate an embodiment of implant delivery system 1800.The implant delivery system 1800 can include a docking tube 1805. Thedocking tube 1805 is connected to an implant torque shaft 1810. In someembodiments, the implant torque shaft 1810 can be rigidly coupled to thedocking tube 1805. In some embodiments, the implant torque shaft 1810 iswelded or soldered to the docking tube 1805. The implant torque shaft1810 can transmit torque to the docking tube 1805, as described herein.The docking tube 1805 can be coupled to the coaptation assistanceelement 400, 500, 600, 700. In the illustrated embodiment, only aportion of the struts 430, 530, 630, 730 are shown.

Referring now to FIGS. 42A-42B, the docking tube 1805 can include one ormore slots 1815. In the illustrated embodiment, the docking tube 1805can include one slot 1815, but other configurations are contemplated(e.g., two slots, three slots, four slots, two diametrically opposedslots, four radially spaced slots, etc.). The slot 1815 can extendthrough the docking tube 1815. In some embodiments, the docking tube1805 can include one or more grooves, which do not extend through thedocking tube. The slots 1815 can extend along the length of the dockingtube 1805, or a portion thereof. The slots 1815 can extend between adistal end and a proximal end of the docking tube 1805.

The docking tube 1805 can include a pin 1820 disposed within the slot1815. In some embodiments, the docking tube 1805 can include a spring1825 disposed within the slot 1815. The pin 1820 can be coupled to apullwire 1830. The pullwire 1830 can cause the pin 1820 to move withinthe slot 1815, as described herein. The annular hub 420, 520, 620, 720can include a groove 1835. The groove 1835 in the annular hub 420, 520,620, 720 can align with the slot 1815 in the docking tube 1805. The pin1820 can be disposed within the groove 1835.

The annular hub 420, 520, 620, 720 can include an externally threadedportion 425, 525, 625, 725. The docking tube 1805 can include aninternally threaded portion 1840. In some methods of use, the dockingtube 1805 is rotated to engage the docking tube 1805 to the annular hub420, 520, 620, 720. The internally threaded portion 1840 engages theexternally threaded portion 425, 525, 625, 725. The groove 1835 can becut on the outer diameter of the threads on the externally threadedportion 425, 525, 625, 725. The slot 1815 can be cut on the innerdiameter of the internally threaded portion 1840 of the docking tube1805. The slot 1815 can align with the groove 1835. In some embodiments,the slot 1815 can align with the groove 1835 when the docking tube 1805is bottomed out against the coaptation assistance element 400, 500, 600,700.

FIGS. 42A-42B illustrate a neutral position of the pin 1820. The spring1825 biases the pin 1820 downward and into engagement with the groove1835. The pin 1835 spans between the docking tube 1805 and the annularhub 420, 520, 620, 720. The natural state is with the pin 1820 forward.In this state, the pin 1820 is locking the threaded connection betweenthe internally threaded portion 1840 of the docking tube 1805 and theexternally threaded portion 425, 525, 625, 725 of the annular hub 420,520, 620, 720. The pin 1820 allows the user to torque the coaptationassistance element 400, 500, 600, 700 in both directions via the dockingtube 1805 and the implant torque shaft 1810. The pin 1820 allows theuser to rotate the coaptation assistance element 400, 500, 600, 700clockwise or counterclockwise by rotating the docking tube 1805. In somemethods of use, the pin 1820 can facilitate movement of the coaptationassistance element 400, 500, 600, 700 via the docking tube 1805. Whenthe slot 1815 and the groove 1835 are aligned, the spring-loaded pin1820 can slip into the groove 1835 and essentially jam the threads. FIG.42A shows the pin 1820 forward such that the docking tube 1805 and thecoaptation assistance element 400, 500, 600, 700 are locked together.FIG. 42B shows a cross-sectional view of the locking pin 1820 in itsnatural forward position.

FIG. 42C-42D show the release of the pin 1820. The pin 1820 can bepulled back via the pullwire 1830. The pin 1820 can compress the spring1825. The pin 1820 can be removed from the groove 1835. The pin 1820slides along the slot 1815. In this position, the docking tube 1805 canbe unscrewed from the coaptation assistance element 400, 500, 600, 700.The internally threaded portion 1840 can be disengaged from theexternally threaded portion 425, 525, 625, 725 by rotation of thedocking tube 1805. FIG. 42C shows a cross-sectional view of theretracted pin 1820. With the pin 1820 retracted, the docking tube 1805can be unscrewed from the annular hub 420, 520, 620, 720. FIG. 42A-42Dillustrate that the docking hub 1805 can be coupled to the coaptationassistance element 400, 500, 600, 700 in order to position thecoaptation assistance element 400, 500, 600, 700. FIG. 42A-42Dillustrate that the docking hub 1805 can be coupled to the coaptationassistance element 400, 500, 600, 700 in order to rotate the coaptationassistance element 400, 500, 600, 700.

FIG. 42E-42 i illustrate the use of the anchor 800 with the implantdelivery system 1800. The anchor 800 is located within the docking hub1805 as shown in FIG. 42E. The anchor 800 is in a retracted state withinthe docking hub 1805. The anchor 800 is internal to the lockingmechanism or pin 1820. The docking hub 1805 is shown in line form, orpenciled in. The docking hub 1805 and the implant torque shaft 1810shown in FIG. 42E are removed in FIG. 42F for clarity.

The anchor 800 can be screwed in at the anatomical P2 position on theposterior leaflet, as described herein. The anchor 800 can be consideredthe P2 anchor. The anchor 800 can be driven by a driver 1845. FIG. 42Gshows a close-up view of the driver 1845. The driver 1845 has driven theanchor 800 fully into the issue and down onto the annular hub 420, 520,620, 720 of the coaptation assistance element 400, 500, 600, 700. Thedriver 1845 is connected to an internal torque shaft 1850. The driver1845 and the anchor 800 are fully housed within the docking hub 1805 asdescribed herein. The internal torque shaft 1850 can extend through theimplant torque shaft 1810, see FIG. 42E.

FIG. 42H shows an internal, cross-sectional view of the anchor 800. Toensure a secure connection to the driver 1845, the anchor 800 can betensioned against the driver 1845 by a tether rail 1855. The tether rail1855 can include a guidewire with a small screw or externally threadedportion 1860 at the distal tip. The externally threaded portion 1860 ofthe tether rail 1855 is configured to engage an internally threadedportion 1865 of the anchor 800. The internal view of the tether rail1855 as well as the connection between the anchor 800 and the annularhub 420, 520, 620, 720 is shown in FIG. 42H

FIG. 42H also shows a square recess 1870 of the head of the anchor 800.The driver 1845 can include a square portion (not shown) configured toengage the square recess 1870 in the head of the anchor 800. Otherdesigns for mating the anchor 800 and the driver 1845 are contemplated(e.g., any non-round shape, polygonal, hex, Philips, elliptical, etc.).

The anchor 800 can include a shoulder 1875. Once the anchor 800 iscompletely driven into the tissue, the shoulder 1875 of the anchor 800pushes the annular hub 420, 520, 620, 720 down to secure the coaptationassistance element 400, 500, 600, 700. FIG. 42 i shows the view of theanchored coaptation assistance element 400, 500, 600, 700.

FIGS. 43A-43E illustrate an embodiment of an implant delivery system1900. The implant delivery system 1900 can include a docking tube 1905.The docking tube 1905 can be cylindrical. The docking tube 1905 isconnected to an implant torque shaft 1910. In some embodiments, theimplant torque shaft 1910 can be rigidly coupled to the docking tube1905. In some embodiments, the implant torque shaft 1910 is welded orsoldered to the docking tube 1905. The implant torque shaft 1910 cantransmit torque to the docking tube 1905, as described herein. Thedocking tube 1905 can be coupled to the coaptation assistance element400, 500, 600, 700. In the illustrated embodiment, only a portion of thestruts 430, 530, 630, 730 are shown.

The docking tube 1905 can include two or more hypotubes 1915 embedded inthe wall. The hypotubes 1915 can include a lumen. The hypotubes 1915 canbe diametrically opposed. The hypotubes 1915 can be spaced 180° apart.The hypotubes 1915 can extend within a slot. The hypotubes 1915 canextend along a portion of the length of the docking tube 1905. In someembodiments, the docking tube 1905 comprises two or more lumens. In someembodiments, the lumens are monolithically or integrally formed with thedocking tube 1905. In the illustrated embodiment, the docking tube 1905can include two hypotubes 1915, but other configurations arecontemplated (e.g., four hypotubes, etc.).

The docking tube 1905 can include tether 1920 disposed within thehypotubes 1915. In some embodiments, the tether 1920 can be loopedthrough opposing gaps in the coaptation assistance element 400, 500,600, 700. In some embodiments, the tether 1920 can be threaded betweenstruts 430, 530, 630, 730 in the coaptation assistance element 400, 500,600, 700. The tether 1920 can extend through one hypotube 1915, throughthe coaptation assistance element 400, 500, 600, 700, underneath theannular hub 420, 520, 620, 720, through the coaptation assistanceelement 400, 500, 600, 700, and through the other hypotube 1915. Thetether 1920 can loop through the coaptation assistance element 400, 500,600, 700. The tether 1920 can loop through the coaptation assistanceelement 400, 500, 600, 700 and back up to the proximal or handle end ofthe system.

FIGS. 43A-43B illustrate an initial position of the tether 1920. In thisstate, the tether 1920 holds the docking tube 1905 and coaptationassistance element 400, 500, 600, 700 together. The tether 1920 allowsthe user to torque the coaptation assistance element 400, 500, 600, 700in both directions via the docking tube 1905 and the implant torqueshaft 1910. The tether 1920 allows the user to rotate the coaptationassistance element 400, 500, 600, 700 clockwise or counterclockwise byrotating the docking tube 1905. In some methods of use, the tether 1920can facilitate movement of the coaptation assistance element 400, 500,600, 700 via the docking tube 1905. The tether 1920 can be released.With the tether 1920 released, the docking tube 1905 can be uncoupledfrom the annular hub 420, 520, 620, 720. FIG. 43A-43B illustrates thatthe docking hub 1905 can be coupled to the coaptation assistance element400, 500, 600, 700 in order to position the coaptation assistanceelement 400, 500, 600, 700. FIG. 43A-43B illustrate that the docking hub1805 can be coupled to the coaptation assistance element 400, 500, 600,700 in order to rotate the coaptation assistance element 400, 500, 600,700.

FIG. 43C-43E illustrate the use of the anchor 800 with the implantdelivery system 1900. The anchor 800 is located within the docking hub1905 as shown in FIG. 43C. The anchor 800 is in a retracted state withinthe docking hub 1905. The anchor 800 is internal to the lockingmechanism or tether 1920. The docking hub 1905 is shown in line form inFIG. 43B.

The anchor 800 can be screwed in at the anatomical P2 position on theposterior leaflet, as described herein. The anchor 800 can be consideredthe P2 anchor. The anchor 800 can be driven by a driver 1945. FIG. 43Dshows a close-up view of the driver 1945. The driver has driven theanchor 800 fully into the tissue and down onto the annular hub 420, 520,620, 720 of the coaptation assistance element 400, 500, 600, 700. Thedriver 1945 is connected to an internal torque shaft 1950. In someembodiments, the internal torque shaft 1950 is welded or soldered to thedriver 1945. The driver 1945 and the anchor 800 are fully housed withinthe docking hub 1905. The internal torque shaft 1950 can extend throughthe implant torque shaft 1910. FIG. 43C illustrates advancement of theanchor 800 prior to full seating of the anchor 800. FIG. 43D shows theanchor 800 screwed down into tissue.

FIG. 43C also shows an internal, cross-sectional view of the anchor 800.To ensure a secure connection to the driver 1945, the anchor 800 can betensioned against the driver 1945 by a tether rail 1955. The tether rail1955 can include a guidewire with a small screw or externally threadedportion 1960 at the distal tip. The externally threaded portion 1960 ofthe tether rail 1955 is configured to engage an internally threadedportion 1965 of the anchor 800. The internal view of the tether rail1955 as well as the connection between the anchor 800 and the annularhub 420, 520, 620, 720 is shown in FIG. 42C. The tether rail 1955 canallow for minimal force evaluation of the effectiveness of thecoaptation assistance element 400, 500, 600, 700 prior to release of thecoaptation assistance element 400, 500, 600, 700. The tether rail 1955can allow for minimal force evaluation of the effectiveness of thecoaptation assistance element 400, 500, 600, 700 prior to release oftether 1920. FIG. 43C illustrates a cross-sectional view showing thepath of the tether 1920.

FIG. 43E shows the view of the implanted anchor 800. FIG. 42E also showsa square recess 1970 of the head of the anchor 800. The driver 1945 caninclude a square portion (not shown) configured to engage the squarerecess 1970 in the head of the anchor 800. Other designs for mating theanchor 800 and the driver 1945 are contemplated (e.g., any non-roundshape, polygonal, hex, Philips, elliptical, etc.). The anchor 800 cancomprise an anchor hub. The hub can include the internally threadedportion 1965 of the anchor 800 to allow for a connection to the tetherrail 1955. The anchor 800 can include an anchor helix. The anchor helixcan include a ground tip for optimal tissue penetration.

The coaptation assistance element 400, 500, 600, 700 can include somecutouts to minimize the sliding friction of the tether 1920. The anchor800 can be screwed into the tissue and bottomed out on the hub 420, 520,620, 720. The user can retract the docking tube 1905 leaving behind thetwo ends of the tether 1920. The tether can be connected via aconnecting inner torque shaft. If the user is satisfied with theperformance of the coaptation assistance element 400, 500, 600, 700, theuser can remove the tether 1920. If the user is unsatisfied with theperformance of the coaptation assistance element 400, 500, 600, 700, theuser can re-dock the implant delivery system 1900 with the tether 1920.If the user is unsatisfied with the performance of the coaptationassistance element 400, 500, 600, 700, the user can thread the tether1920 through the hypotubes 1915. If the user is unsatisfied with theperformance of the coaptation assistance element 400, 500, 600, 700, theuser can remove the anchor 800 and/or remove the coaptation assistanceelement 400, 500, 600, 700 entirely.

FIGS. 44A-44E illustrate an embodiment of an implant delivery system2000. The implant delivery system 2000 can include a docking tube 2005.The docking tube 2005 can be a desired shape, such as cylindrical forexample. The docking tube 2005 is connected to an implant torque shaft2010. In some embodiments, the implant torque shaft 2010 can be rigidlycoupled to the docking tube 2005. In some embodiments, the implanttorque shaft 2010 is welded or soldered to the docking tube 2005. Theimplant torque shaft 2010 can transmit torque to the docking tube 2005,as described herein. The docking tube 2005 can include a docking endcap2015.

The docking tube 2005 can include one, two, or more retention arms 2020cut out at the distal end. The one, two, or more retention arms 2020 canallow for the transfer of torque as well as push/push to the coaptationassistance element 400, 500, 600, 700 via the implant torque shaft 2010.The docking tube 2005 can include three retention arms 2020. Theretention arms 2020 can be equally spaced around the docking tube 2005.The retention arms 2020 can be spaced about, at least about, or no morethan about 120° apart or another desired angle. The retention arms 2020can extend along a portion of the length of the docking tube 2005. Insome embodiments, the retention arms 2020 are monolithically orintegrally formed with the docking tube 2005. In the illustratedembodiment, the docking tube 2005 can include three retention arms 2020,but other configurations are contemplated (e.g., one retention arm, tworetention arms, four retention arms, five retention arms, etc.). Theretention arms 2020 can be formed from a U-shaped cut in the dockingtube 2005.

FIGS. 44B-44C illustrate an initial position of the retention arms 2020.In this state, the retention arms 2020 hold the docking tube 2005 andcoaptation assistance element 400, 500, 600, 700 together. The retentionarms 2020 allow the user to torque the coaptation assistance element400, 500, 600, 700 in both directions via the docking tube 2005 and theimplant torque shaft 2010. The retention arms 2020 allow the user torotate the coaptation assistance element 400, 500, 600, 700 clockwise orcounterclockwise by rotating the docking tube 2005. In some methods ofuse, the retention arms 2020 can facilitate movement of the coaptationassistance element 400, 500, 600, 700 via the docking tube 2005.

Referring to FIG. 44E, the retention arms 2020 engage windows 2025 inthe head of the anchor 800. In some embodiments, the windows 2025 arelaser cut windows. In some embodiments, the windows 2025 extend throughthe annular hub 420, 520, 620, 720. In some embodiments, the windows2025 are slots or grooves. The number of windows 2025 can correspond tothe number of retention arms 2020. In some embodiments, each retentionarms 2020 engages a window 2025. The windows 2025 can be shaped toaccept a portion of a retention arm 2020 such as a tab 2030. In someembodiments, each retention arm 2020 can include an inwardly facing tab2030. The tab 2030 can have an increased thickness relative to theretention arm 2020. The tab 2030 can be shaped to engage the window2025. The tab 2030 can be a distal inner section of the retention arm2020.

FIG. 44B-44D illustrate the use of the anchor 800 with the implantdelivery system 2000. The anchor 800 is located within the docking hub2005 as shown in FIG. 44B. The anchor 800 is in a retracted state withinthe docking hub 2005. The anchor 800 is internal to the lockingmechanism or tabs 2030 of the retention arms 2020. The docking hub 2005is shown in line form in FIG. 44B. FIG. 44C shows advance of the anchor800. FIG. 44C illustrate anchor 800 advancement prior to full seating ofthe anchor 800 and prior to flexing of the retention arms 2020.

The anchor 800 can be screwed in, for example, at the anatomical P2position on the posterior leaflet, as described herein. The anchor 800can be considered the P2 anchor. The anchor 800 can be driven by adriver 2045. FIG. 44D shows a close-up view of the driver 2045. Thedriver 2045 has driven the anchor 800 fully into the issue and down ontothe annular hub 420, 520, 620, 720 of the coaptation assistance element400, 500, 600, 700. The driver 2045 is connected to an internal torqueshaft 2050. In some embodiments, the internal torque shaft 2050 iswelded or soldered to the driver 2045. The driver 2045 and the anchor800 are fully housed within the docking hub 2005 as shown in FIG. 44B.The internal torque shaft 2050 can extend through the implant torqueshaft 2010.

FIG. 44D shows an internal, cross-sectional view of the anchor 800. Toensure a secure connection to the driver 2045, the anchor 800 can betensioned against the driver 2045 by a tether rail 2055. The tether rail2055 can include a guidewire with a small screw or externally threadedportion 2060 at the distal tip. The externally threaded portion 2060 ofthe tether rail 2055 is configured to engage an internally threadedportion 2065 of the anchor 800. The internal view of the tether rail2055 as well as the connection between the anchor 800 and the annularhub 420, 520, 620, 720 is shown in FIG. 44D. The tether rail 2055 canallow for minimal force evaluation of the effectiveness of thecoaptation assistance element 400, 500, 600, 700 prior to release of thecoaptation assistance element 400, 500, 600, 700. The tether rail 2055can allow for minimal force evaluation of the effectiveness of thecoaptation assistance element 400, 500, 600, 700 prior to release ofretention arms 2020.

FIG. 44D illustrates a cross-sectional view showing the release of theretention arms 2020. When the anchor 800 is screwed into tissue, theannular hub 420, 520, 620, 720 makes contact with the tabs 2030 of theretention arms 2020. The retention arms 2020 can bend outward from thewindows 2025 of the anchor 800 due to the distal movement of the annularhub 420, 520, 620, 720. The tabs 2030 can include angled faces 2035which allow for easy removal of the docking tube 2005 from the annularhub 420, 520, 620, 720 when the retention arms 2020 are bent outward.FIG. 44D illustrate anchor 800 advancement wherein the retention arms2020 bend outward as the anchor 800 is fully driven in.

With the retention arms 2020 bent outward, the docking tube 2005 can beuncoupled from the annular hub 420, 520, 620, 720. FIG. 44D illustratesthat the docking hub 2005 can be uncoupled to the coaptation assistanceelement 400, 500, 600, 700. FIGS. 44A-44C illustrates that the dockinghub 2005 can be coupled to the coaptation assistance element 400, 500,600, 700 in order to position the coaptation assistance element 400,500, 600, 700. FIGS. 44A-44C illustrate that the docking hub 2005 can becoupled to the coaptation assistance element 400, 500, 600, 700 in orderto rotate the coaptation assistance element 400, 500, 600, 700.

FIG. 44E shows the view of the implanted anchor 800. FIG. 44E also showsa square recess 2070 of the head of the anchor 800. The driver 2045 caninclude a square portion (not shown) configured to engage the squarerecess 2070 in the head of the anchor 800. Other designs for mating theanchor 800 and the driver 2045 are contemplated (e.g., any non-roundshape, polygonal, hex, Philips, elliptical, etc.). The anchor 800 cancomprise an anchor hub. The hub can include the internally threadedportion 2065 of the anchor 800 to allow for a connection to the tetherrail 2055. The anchor 800 can include an anchor helix. The anchor 800can include the windows 2025. The windows 2025 allow the retention arms2020 to snap in and hold onto the annular hub 420, 520, 620, 720. Thewindows 2025 allow the retention arms 2020 hold onto the annular hub420, 520, 620, 720 in compression, tension and torsion.

FIGS. 45A-45K illustrate an embodiment of an implant delivery system2100. The implant delivery system 2100 can include a docking tube 2105.The docking tube 2105 can be cylindrical. The docking tube 2105 isconnected to an implant torque shaft 2110. In some embodiments, theimplant torque shaft 2110 can be rigidly coupled to the docking tube2105. In some embodiments, the implant torque shaft 2110 is welded orsoldered to the docking tube 2105. The implant torque shaft 2110 cantransmit torque to the docking tube 2105, as described herein. Thedocking tube 2105 can include a docking endcap 2115.

The docking tube 2105 can include one or more slots 2120 cut out at thedistal end. The slot 2120 can be a bayonet slot. The slot 2120 can havea bayonet configuration. The one or more slots 2120 can allow for thetransfer of torque as well as push/push to the coaptation assistanceelement 400, 500, 600, 700 via the implant torque shaft 2110. Thedocking tube 2105 can include three slots 2120. The slots 2120 can beequally spaced around the docking tube 2105. The slots 2120 can bespaced 120° apart. The slots 2120 can extend along a portion of thelength of the docking tube 2105. In some embodiments, the slots 2120 aremonolithically or integrally formed with the docking tube 2105. In theillustrated embodiment, the docking tube 2105 can include three slots2120, but other configurations are contemplated (e.g., one slot, twoslots, four slots, five slots, etc.). The slots 2120 can be formed froma J-shaped cut in the docking tube 2105.

The docking tube 2105 can include a flared ring 2125 shown in FIG. 45B.The flared ring 2125 can ensure that the slots 2120 do not weaken thedistal end of the docking tube 2105. The flared ring 2125 can ensure theease of re-docking. The flared ring 2125 can be welded or soldered tothe distal end of the docking tube 2105.

Referring to FIG. 45F, the slots 2120 engage retention pins 2030 in thehead of the anchor 800. In some embodiments, the retention pins 2030protrude a sufficient amount to ensure proper interface with the slots2120 at the tip of the docking tube 2105. In some embodiments, theretention pins 2030 extend radially outward from the annular hub 420,520, 620, 720. In some embodiments, the retention pins 2030 arecylindrical. The number of retention pins 2030 can correspond to thenumber of slots 2120. In some embodiments, each slot 2120 engages aretention pin 2025. The slots 2120 can be shaped to accept and guide theretention pins 2030.

FIGS. 45B-45C illustrate an initial position of the slots 2120 relativeto retention pins 2030. In this state, the slots 2120 and retention pins2030 hold the docking tube 2005 and coaptation assistance element 400,500, 600, 700 together. The slots 2120 and retention pins 2030 allowsthe user to torque the coaptation assistance element 400, 500, 600, 700in both directions via the docking tube 2005 and the implant torqueshaft 2010. The slots 2120 and retention pins 2030 allow the user torotate the coaptation assistance element 400, 500, 600, 700 clockwise orcounterclockwise by rotating the docking tube 2005. In some methods ofuse, the slots 2120 and retention pins 2030 can facilitate movement ofthe coaptation assistance element 400, 500, 600, 700 via the dockingtube 2105.

FIG. 45B-45E illustrate the use of the anchor 800 with the implantdelivery system 2100. The anchor 800 is located within the docking hub2105 as shown in FIG. 45B. The anchor 800 is in a retracted state withinthe docking hub 2105. The anchor 800 is internal to the lockingmechanism or the slots 2120. The docking hub 2105 is shown in line formin FIG. 45B. FIG. 45C shows advancement of the anchor 800.

The anchor 800 can be screwed in at the anatomical P2 position on theposterior leaflet, as described herein. The anchor 800 can be consideredthe P2 anchor. The anchor 800 can be driven by a driver 2145. FIG. 45Dshows a close-up view of the driver 2145. The driver 2145 has driven theanchor 800 fully into the tissue and down onto the annular hub 420, 520,620, 720 of the coaptation assistance element 400, 500, 600, 700. Thedriver 2145 is connected to an internal torque shaft 2150. In someembodiments, the internal torque shaft 2150 is welded or soldered to thedriver 2145. The driver 2145 and the anchor 800 are fully housed withinthe docking hub 2105 as shown in FIG. 45B. The internal torque shaft2150 can extend through the implant torque shaft 2110.

FIG. 45E shows an internal, cross-sectional view of the anchor 800. Toensure a secure connection to the driver 2145, the anchor 800 can betensioned against the driver 2145 by a tether rail 2155. The tether rail2155 can include a guidewire with a small screw or externally threadedportion 2160 at the distal tip. The externally threaded portion 2160 ofthe tether rail 2155 is configured to engage an internally threadedportion 2165 of the anchor 800. The internal view of the tether rail2055 as well as the connection between the anchor 800 and the annularhub 420, 520, 620, 720 is shown in FIG. 45E. The tether rail 2155 canallow for minimal force evaluation of the effectiveness of thecoaptation assistance element 400, 500, 600, 700 prior to release of thecoaptation assistance element 400, 500, 600, 700. The tether rail 2155can allow for minimal force evaluation of the effectiveness of thecoaptation assistance element 400, 500, 600, 700 prior to release ofretention pins 2030.

When the anchor 800 is screwed into tissue, the retention pins 2030 ofthe annular hub 420, 520, 620, 720 moves proximally within the slots2120. The docking tube 2005 can be rotated, thereby moving the retentionpins 2030 of the annular hub 420, 520, 620, 720 laterally within theslots 2120. The docking tube 2005 can be moved proximally, therebymoving the retention pins 2030 of the annular hub 420, 520, 620, 720distally within the slots 2120. Further movement of the docking tube2005 proximally can release the docking tube 2105 from the annular hub420, 520, 620, 720. FIGS. 45A-45C illustrates that the docking hub 2005can be coupled to the coaptation assistance element 400, 500, 600, 700in order to position the coaptation assistance element 400, 500, 600,700. FIGS. 45A-45C illustrate that the docking hub 2105 can be coupledto the coaptation assistance element 400, 500, 600, 700 in order torotate the coaptation assistance element 400, 500, 600, 700.

FIG. 45E-45F show the view of the implanted anchor 800. FIG. 45E alsoshows a square recess 2170 of the head of the anchor 800. The driver2145 can include a square portion (not shown) configured to engage thesquare recess 2170 in the head of the anchor 800. Other designs formating the anchor 800 and the driver 2145 are contemplated (e.g., anynon-round shape, polygonal, hex, Philips, elliptical, etc.). The anchor800 can comprise an anchor hub. The hub can include the internallythreaded portion 2165 of the anchor 800 to allow for a connection to thetether rail 2155. The anchor 800 can include an anchor helix. In someembodiments, the annular hub 420, 520, 620, 720 can include three lasercut holes to accept the three retention pins 2130. The retention pins2130 can be welded to the holes. In some embodiments, the retention pins2130 are nitinol. FIGS. 45G-45K show additional views.

FIGS. 45A-45C illustrate deploying one or more secondary anchors 850,1770, 1780. The secondary anchor 850, 1770, 1780 can include any of thefeatures of the anchor 800. The secondary anchor 850, 1770, 1780 cancomprise a helix or helical structure 852. The secondary anchor 850,1770, 1780 can be designed to engage the tissue of heart, such as thetissue of the annulus. The secondary anchor 850, 1770, 1780 can includea tip 854 designed to engage tissue. The tip 854 can be sharpened. Thetip 854 can be ground for optimal penetration. The secondary anchor 850,1770, 1780 can include a hub 856. The hub 856 can be an annular hubhaving any of the features of annular hub 420, 520, 620, 720 describedherein. The hub 856 can include one or more mating features 858. Themating feature 858 can be a cutout. The mating feature 858 can createtwo semi-circular portions at different heights. The mating feature 858can include a first circular portion and a second circular portion. Thefirst and second circular portions can be separated by a perpendicularcut. The mating feature 858 can include any configuration which allowstorque to be transmitted to the secondary anchor 850, 1770, 1780.

FIGS. 46A-46C illustrate a delivery catheter 860 designed for deployingone or more secondary anchors 850, 1770, 1780. The distal end of thedelivery catheter 860 is shown in the figures. The delivery catheter 860can include a proximal end outside the body of the patient. The proximalend can include one or more controls to manipulate the delivery catheter860. The delivery catheter 860 can include a torque shaft 862. In someembodiments, the torque shaft 862 can rotate the secondary anchors 850,1770, 1780 in either direction. The torque shaft 862 can include a lumen864. The torque shaft 862 can include a helix or helical structure 866.The helix or helical structure 866 of the torque shaft 862 can have thesame or similar features as the helix or helical structure 852 of theone or more secondary anchors 850, 1770, 1780. The helix or helicalstructure 866 of the torque shaft 862 can have the same pitch as thehelix or helical structure 852 of the one or more secondary anchors 850,1770, 1780. The helix or helical structure 866 of the torque shaft 862can have the same diameter as the helix or helical structure 852 of theone or more secondary anchors 850, 1770, 1780. The helix or helicalstructure 866 of the torque shaft 862 can have the same wire diameter asthe helix or helical structure 852 of the one or more secondary anchors850, 1770, 1780.

The delivery catheter 860 can include a locking hub 868. The locking hub868 can be an annular hub. The locking hub 868 can include one or moremating features 870. The mating feature 870 can be designed to lock withthe mating feature 858 of the hub 856. The mating feature 870 can createtwo semi-circular portions at different heights. The mating feature 870can include a first circular portion and a second circular portion. Thefirst and second circular portions can be separated by a perpendicularcut. The mating feature 870 can include any configuration which allowstorque to be transmitted to the hub 856 of the one or more secondaryanchors 850, 1770, 1780. The locking hub 868 can be coupled to a lockingshaft 872.

FIG. 46A shows a configuration in which the delivery catheter 860 is notengaged with the secondary anchor 850, 1770, 1780. FIG. 46B shows aconfiguration in which the delivery catheter 860 is engaged with thesecondary anchor 850, 1770, 1780. In some embodiments, the helix orhelical structure 866 can engage the helix or helical structure 852 ofthe secondary anchor 850, 1770, 1780. In some embodiments, both helicescan have the same pitch and diameter. Because both helices have samepitch and diameter, the combined profile will be the same as the profileof the secondary anchor 850, 1770, 1780. The helix or helical structure866 can interlock with the helix or helical structure 852 of thesecondary anchor 850, 1770, 1780. The helix or helical structure 866 canfit within the voids of the helix or helical structure 852 of thesecondary anchor 850, 1770, 1780. The diameter of the combined structurecan be the same as the diameter of the helix or helical structure 852 ofthe secondary anchor 850, 1770, 1780. In some embodiments, the torqueshaft 862 can be rotated to engage the helix or helical structure 866with the helix or helical structure 852 of the secondary anchor 850,1770, 1780. In some embodiments, the secondary anchor 850, 1770, 1780can be rotated to engage the helix or helical structure 852 of thesecondary anchor 850, 1770, 1780 with the helix or helical structure866. FIG. 46B shows the engaged helices.

In some embodiments, the locking hub 868 is engaged with the hub 856 ofthe secondary anchor 850, 1770, 1780. In some embodiments, the lockinghub 868 can be translated within the lumen 864 of the torque shaft 862toward the secondary anchor 850, 1770, 1780. The mating feature 870 ofthe locking hub 868 can interlock with the mating feature 858 of the hub565 of the secondary anchor 850, 1770, 1780. The locking hub 868 canengage the secondary anchor 850, 1770, 1780. The hub 856 of thesecondary anchor 850, 1770, 1780 and the locking hub 868 are engaged toconnect the secondary anchor 850, 1770, 1780 to the delivery catheter860. In some embodiments, the locking shaft 872 can advance or withdrawthe locking hub 868.

FIG. 46C shows the locking hub 868 engaged with the hub 856 of thesecondary anchor 850, 1770, 1780. The locking hub 868 engaged with thehub 856 allow rotation of the secondary anchor 850, 1770, 1780. In someembodiments, the locking hub 868 engaged with the hub 856 can reduce thelikelihood of disengagement of the delivery catheter 860 from thesecondary anchor 850, 1770, 1780 during delivery. In some embodiments,the locking hub 868 engaged with the hub 856 allow counter-clockwiserotation of the secondary anchor 850, 1770, 1780 without disengagingfrom the delivery catheter 860. The secondary anchor 850, 1770, 1780 canbe rotated counter-clockwise to be driven into tissue.

Once the secondary anchor 850, 1770, 1780 is driven into tissue, thedelivery catheter 860 can be disengaged from the secondary anchor 850,1770, 1780. In some embodiments, the locking hub 868 can be disengagedwith the hub 856 of the secondary anchor 850, 1770, 1780. The lockinghub 868 can be translated within the lumen 864 of the torque shaft 862away from the secondary anchor 850, 1770, 1780. The locking shaft 872can withdraw the locking hub 868. In some embodiments, the torque shaft862 can be rotated to disengage the helices. In some embodiments, thetorque shaft 862 can be rotated to disengage the helix or helicalstructure 866 with the helix or helical structure 852 of the secondaryanchor 850, 1770, 1780.

In some embodiments, the coaptation assistance element 400, 500, 600,700 can include an annular section configured to be implanted within aheart superior to a valve annulus. In some embodiments, the coaptationassistance element 400, 500, 600, 700 can include a plurality of strutscomprising at least a first strut residing within the annular sectionand a second strut having a total length that is longer than that of thefirst strut. In some embodiments, the coaptation assistance element 400,500, 600, 700 can include a superior edge which is cupped and carried byannular section. In some embodiments, the coaptation assistance element400, 500, 600, 700 can improve the entire length coaptation withoutdisrupting the anatomy. In some embodiments, the coaptation assistanceelement 400, 500, 600, 700 can include a plurality of radial struts. Insome embodiments, the coaptation assistance element 400, 500, 600, 700can include a plurality of radial struts comprising first strutsresiding within the annular section and second struts having a totallength that is longer than that of the first struts. In someembodiments, the coaptation assistance element 400, 500, 600, 700includes a superior edge which is cupped. In some embodiments, thecoaptation assistance element 400, 500, 600, 700 can include a hubpositioned near the annulus. In some embodiments, the coaptationassistance element 400, 500, 600, 700 can include struts which areradially expanding. In some embodiments, the coaptation assistanceelement 400, 500, 600, 700 can include improving coaptation of strutsover the entire length without disrupting the anatomy. In someembodiments, the coaptation assistance element 400, 500, 600, 700 can beexpanded via the struts.

In some methods, the method can include positioning the hub near theannulus. In some methods, the struts are radially expanding. In somemethods, the method can include improving coaptation of struts over theentire length without disrupting anatomy. In some methods, the methodcan include expansion of the coaptation element carried via the strutsextending radially outward. In some methods, the method can includeexpansion of the coaptation element carried via the struts extendingradially outward to form an annulus section. In some methods, the methodcan include expansion of the coaptation element carried via the strutsforming an annulus section.

In some embodiments, the annular hub 420, 520, 620, 720 is spaced inwardfrom the lateral edges of the coaptation assistance element 400, 500,600, 700. In some embodiments, the annular hub 420, 520, 620, 720 isspaced inward from the superior edge of the coaptation assistanceelement 400, 500, 600, 700. In some embodiments, the annular hub 420,520, 620, 720 is spaced inward from the inferior edge of the coaptationassistance element 400, 500, 600, 700. In some embodiments, the annularhub 420, 520, 620, 720 is not expandable. In some embodiments, theannular hub 420, 520, 620, 720 has a fixed circumference. In someembodiments, the annular hub 420, 520, 620, 720 retains the shape duringexpansion of the coaptation assistance element 400, 500, 600, 700. Insome embodiments, the annular hub 420, 520, 620, 720 is formed from atube. The struts 430, 530, 630, 730 can be laser cut from the tube. Thecuts can extend from one end of the tubing toward the second end. Theuncut portion of the tubing can be annular hub 420, 520, 620, 720. Insome embodiments, the coaptation assistance element 400, 500, 600, 700can be formed from a sheet of material. The sheet can be laser cut toinclude the struts 430, 530, 630, 730. The sheet can be rolled to form atube. The tube can be welded or otherwise held together. The uncutportion of the sheet can form the annular hub 420, 520, 620, 720.

In some embodiments, the anchor 800 is an active anchor. The anchor 800can be coupled to the annular hub 420, 520, 620, 720. The anchor 800 canbe coupled to the annular hub 420, 520, 620, 720 by interlocking thehelix of the anchor 800 with a structure of the annular hub 420, 520,620, 720. The anchor 800 can be configured to be rotated relative to theannular hub 420, 520, 620, 720. The anchor 800 can be configured to berotated relative to the annular hub 420, 520, 620, 720 when coupled tothe annular hub 420, 520, 620, 720. The anchor 800 is configured to berotated to be selectively deployed. The anchor 800 is configured to berotated to engage tissue. The anchor 800 is configured to be rotated toengage the annulus. The anchor 800 is configured to be rotated throughthe annulus. The anchor 800 is configured to be rotated in a firstdirection relative the annular hub 420, 520, 620, 720. The anchor 800 isconfigured to be rotated in a first direction to selectively deploy theanchor 800. The anchor 800 is configured to be rotated to deploy theanchor 800 at a first target location. The anchor 800 is configured tobe rotated to engage tissue in the annulus. The anchor 800 can beselectively deployed in the annulus. The annular hub 420, 520, 620, 720can remain stationary as the anchor 800 is rotated to engage tissue. Thenon-expandable, annular hub 420, 520, 620, 720 can remain stationary asthe anchor 800 is rotated to engage tissue.

In some embodiments, the anchor 800 is configured to be rotated in asecond direction relative the annular hub 420, 520, 620, 720. The anchor800 is configured to be rotated in a second direction to selectivelydisengage the anchor 800. The anchor 800 is configured to be rotated todisengage the anchor 800 from the first target location. The anchor 800is configured to be rotated to disengage tissue in the annulus. Theannular hub 420, 520, 620, 720 can remain stationary as the anchor 800is rotated to disengage tissue. The non-expandable, annular hub 420,520, 620, 720 can remain stationary as the anchor 800 is rotated todisengage tissue. The second direction can be opposite the firstdirection. In some embodiments, the first direction can be clockwise andthe second direction can be counter-clockwise. In some embodiments, thefirst direction can be counter-clockwise and the second direction can beclockwise.

In some embodiments, the plurality of struts 430, 530, 630, 730 arespaced circumferentially around the annular hub 420, 520, 620, 720. Insome embodiments, the plurality of struts 430, 530, 630, 730 are evenlyspaced around the annular hub 420, 520, 620, 720. In some embodiments,the plurality of struts 430, 530, 630, 730 are unevenly spaced aroundthe annular hub 420, 520, 620, 720. In some embodiments, the struts 430,530, 630, 730 comprising the annular section are evenly spaced aroundthe annular hub 420, 520, 620, 720. In some embodiments, the struts 430,530, 630, 730 comprising the annular section are unevenly spaced aroundthe annular hub 420, 520, 620, 720. In some embodiments, the struts 430,530, 630, 730 forming the superior edge are evenly spaced around theannular hub 420, 520, 620, 720. In some embodiments, the struts 430,530, 630, 730 forming the superior edge are unevenly spaced around theannular hub 420, 520, 620, 720. In some embodiments, the struts 430,530, 630, 730 comprising the ventricular section are evenly spacedaround the annular hub 420, 520, 620, 720. In some embodiments, thestruts 430, 530, 630, 730 comprising the ventricular section areunevenly spaced around the annular hub 420, 520, 620, 720. In someembodiments, the struts 430, 530, 630, 730 forming the inferior edge areevenly spaced around the annular hub 420, 520, 620, 720. In someembodiments, the struts 430, 530, 630, 730 forming the inferior edge areunevenly spaced around the annular hub 420, 520, 620, 720. In someembodiments, two or more struts 430, 530, 630, 730 are evenly spacedaround the annular hub 420, 520, 620, 720. In some embodiments, two ormore 430, 530, 630, 730 are unevenly spaced around the annular hub 420,520, 620, 720.

In some embodiments, the plurality of struts 430, 530, 630, 730 extendoutward from the annular hub 420, 520, 620, 720. In some embodiments,the plurality of struts 430, 530, 630, 730 have a portion near theannular hub 420, 520, 620, 720 which is radial. In some embodiments, theplurality of struts 430, 530, 630, 730 are placed along a radius. Insome embodiments, the plurality of struts 430, 530, 630, 730 divergefrom a center. In some embodiments, the plurality of struts 430, 530,630, 730 diverge from the annular hub 420, 520, 620, 720. In someembodiments, the plurality of struts 430, 530, 630, 730 developuniformly around a central axis. In some embodiments, the plurality ofstruts 430, 530, 630, 730 develop uniformly around the annular hub 420,520, 620, 720. In some embodiments, the plurality of struts 430, 530,630, 730 develop uniformly around the anchor 800. In some embodiments,the plurality of struts 430, 530, 630, 730 can form spokes. In someembodiments, the plurality of struts 430, 530, 630, 730 extend from thecenter outward. In some embodiments, the plurality of struts 430, 530,630, 730 extend from the edge of the coaptation assistance element 400,500, 600, 700 inward. In some embodiments, the plurality of struts 430,530, 630, 730 are branched. In some embodiments, the plurality of struts430, 530, 630, 730 are outspread. In some embodiments, the plurality ofstruts 430, 530, 630, 730 are radiating. In some embodiments, theplurality of struts 430, 530, 630, 730 spread outward. In someembodiments, the plurality of struts 430, 530, 630, 730 can include aninflection point. In some embodiments, a strut 430, 530, 630, 730 caninclude an inflection point. In some embodiments, the plurality ofstruts 430, 530, 630, 730 can include a curved shape. In someembodiments, a strut 430, 530, 630, 730 can include a curved shape. Insome embodiments, a strut 430, 530, 630, 730 can include a U-shapedcurve. In some embodiments, a strut 430, 530, 630, 730 can include aC-shaped curve. In some embodiments, a strut 430, 530, 630, 730 caninclude an S-shaped curve. In some embodiments, a strut 430, 530, 630,730 can include an L-shaped curve.

In some embodiments, the plurality of struts 430, 530, 630, 730 increasethe volume of the coaptation assistance element 400, 500, 600, 700 whendeployed. In some embodiments, the plurality of struts 430, 530, 630,730 increase the thickness of the coaptation assistance element 400,500, 600, 700 when deployed. In some embodiments, the plurality ofstruts 430, 530, 630, 730 increase the length of the coaptationassistance element 400, 500, 600, 700 when deployed. In someembodiments, the plurality of struts 430, 530, 630, 730 increase theheight of the coaptation assistance element 400, 500, 600, 700 whendeployed. In some embodiments, the plurality of struts 430, 530, 630,730 increase the width of the coaptation assistance element 400, 500,600, 700 when deployed.

In some embodiments, the plurality of struts 430, 530, 630, 730 caninclude a first strut. The first strut can be configured to be implantedwithin a heart superior to a valve annulus. The first strut can be anannular strut. In some embodiments, the plurality of struts 430, 530,630, 730 can include a second strut. The second strut can be configuredto be implanted within a heart inferior to a valve annulus. The secondstrut can be a ventricular strut. The second strut can traverse themitral valve. The second strut can traverse a plane of the valveannulus. In some embodiments, the first strut and the second strut havedifferent lengths. In some embodiments, the second strut is longer thanthe first strut.

In some embodiments, the superior edge of the coaptation assistanceelement 400, 500, 600, 700 forms a curve. In some embodiments, thesuperior edge forms a lip. In some embodiments, the superior edge iscupped downward toward the inferior edge. In some embodiments, thesuperior edge is cupped upward from the inferior edge. In someembodiments, the annular hub 420, 520, 620, 720 extends upward from theinferior edge. In some embodiments, the annular hub 420, 520, 620, 720extends upward from the superior edge. In some embodiments, the annularhub 420, 520, 620, 720 extends upward from the annular portion of thecoaptation assistance element 400, 500, 600, 700. In some embodiments,the annular hub 420, 520, 620, 720 extends upward from the coaptationsurface of the coaptation assistance element 400, 500, 600, 700. In someembodiments, the annular hub 420, 520, 620, 720 is tubular. In someembodiments, the annular hub 420, 520, 620, 720 forms a circle. In someembodiments, the annular hub 420, 520, 620, 720 has the form of a ring.In some embodiments, the hub 420, 520, 620, 720 is non-annular. In someembodiments, the hub 420, 520, 620, 720 forms a polygon (e.g.,triangular, square, rectangular, hexagonal, octagonal, etc.). In someembodiments, the hub 420, 520, 620, 720 forms a non-round shape. In someembodiments, the hub 420, 520, 620, 720 forms an elliptical shape.

FIGS. 47A-47E illustrates embodiments of implant features. FIGS. 47A-47Eillustrate some nonlimiting potentially clinically relevant aspects ofthe implant. While the coaptation assistance element 400 is illustrated,any of the coaptation assistance elements described herein can includethe features described herein. In addition, the coaptation assistanceelement 400 can include any of the features of the coaptation assistanceelements described herein with respect to other embodiments, forexample.

As described herein, the coaptation assistance element 400 can includethe annular hub 420 which can be relatively centrally located. Thecoaptation assistance element 400 can have a generally elongate shape,but other shapes are contemplated, for example, polygonal, circular,elliptical, rounded, rectangular, triangular, etc. The coaptationassistance element 400 can have a superior edge 440, lateral edges 470and 475, and inferior edge 480. In some embodiments, the superior edge440 has a length greater than that of inferior edge 480, such that thetransverse distance between lateral edges 470 and 475 generallydecreases from superior to inferior on the coaptation assistance element400. The superior edge 440 of the coaptation assistance element 400 canbe curved to match the general shape of the annulus or adjoining atrialwall.

The coaptation assistance element 400 can include a first surface 405configured to be disposed toward a mal-coapting native leaflet, in use,and a second surface 415 configured to be disposed toward the anteriorleaflet. The second surface 415 can include a coaptation surface 460.The coaptation assistance element 400 can include one or more struts430. The plurality of struts 430 can provide structural support for thecoaptation assistance element 400. The plurality of struts 430 canprovide the deployed shape for the coaptation assistance element 400. Asdescribed herein, the plurality of struts can comprise a shape memorymaterial, such as a shape memory metal or plastic.

In some embodiments, a first strut 430 of the plurality of strutsextends from the annular hub 420 to or toward the superior edge 440. Insome embodiments, a second strut 430 of the plurality of struts extendsfrom the annular hub 420 to or toward the inferior edge 480. In someembodiments, a third strut 430 of the plurality of struts extends fromthe annular hub 420 to or toward the lateral edge 470. In someembodiments, a fourth strut 430 of the plurality of struts extends fromthe annular hub 420 to or toward the lateral edge 475. Any two or moreof the first strut, the second strut, the third strut, or the fourthstrut can include the same features, including material, length, width,thickness, configuration, pre-formed bend, curvature, etc. Any two ormore of the first strut, the second strut, the third strut, or thefourth strut can include different features, including material, length,width, thickness, configuration, pre-formed bend, curvature, etc. Insome embodiments, at least one of the struts, e.g., in the superior zoneof the implant can extend radially outwardly of, and protrude from thecovering 450 of the implant 400 to act as spaced-apart barbs and canassist with anchoring and/or tissue ingrowth in the valve annulus. Insome embodiments, the barbs extend only in the annular zone (e.g.,superior zone) of the implant but are not present in the inferior(leaflet) copation zone which is atraumatic in some embodiments. In someembodiments, the entire peripheral edge of the implant can beatraumatic.

In some embodiments, the struts 430 can be covered with one, two, ormore layers of coaptation assistance element body covering 450. Thecoaptation assistance element body covering 450 can include a layer or aplurality of layers (e.g., one layer, two layers, three layers, fourlayers, five layers, or more, or ranges incorporating any two of theforegoing values). In some embodiments, the first surface 405 caninclude one or more layers. In some embodiments, the second surface 415can include one or more layers. Any two or more layers of the pluralityof layers can include the same or different features, includingmaterial, length, width, thickness, etc. In some embodiments, one ormore layers extend along the entire, or only a portion of the firstsurface 405. In some embodiments, one or more layers extend along theentire, or only a portion of the second surface 415. The layers can beformed from any process described herein.

The coaptation assistance element body covering 450 may be comprised ofa material such as a polymer, e.g., ePTFE. Other materials for thecoaptation assistance element body covering 450 include polyester,polyurethane foam, polycarbonate foam, biologic tissue such as porcinepericardium, processed bovine pericardium, pleura, peritoneum, silicone,Dacron, acellular collagen matrix, combinations thereof, etc. In someembodiments, the coaptation assistance element body covering 450 caninclude a foam material surrounded by ePTFE.

In some embodiments, the struts 430 can be formed with or embedded oneor more layers of coaptation assistance element body covering 450. Insome embodiments, the struts 430 can be encased or at least partiallyencased by the coaptation assistance element body covering 450. In someembodiments, a portion of the strut 430 can extend from the coaptationassistance element body covering 450 to engage tissue as describedelsewhere herein. FIGS. 47A-47E illustrate features which may facilitateinteraction between the coaptation assistance element 400, or a portionthereof, and the native anatomy.

FIG. 47A illustrates the coaptation surface 460, which can define arelatively inferior zone of the implant. The anterior ventricularcoaption surface can be reinforced. As described herein, the coaptationsurface 460 can contact a leaflet of the patient. The coaptationassistance element 400, after placement, can entirely cover theposterior leaflet so that the anterior leaflet coapts with thecoaptation surface 460 during systole. The coaptation assistance element400 and anterior leaflet can maintain the valve seal at the annularring.

In some embodiments, the second surface 415, or a portion thereof, isreinforced. In some embodiments, the coaptation surface 460 isreinforced. The second surface 415 including but not limited to thecoaptation surface 460 can be reinforced with one or more additionallayers. The one or more additional layers can extend over the secondsurface 415 or a portion thereof. The one or more additional layers canextend over the coaptation surface 460 or a portion thereof. The one ormore additional layers can extend over a portion of the second surface415 including the coaptation surface 460. The one or more additionallayers can extend over a portion of the second surface 415 larger thanthe coaptation surface 460.

The coaptation surface 460 can be reinforced with any material describedherein. The coaptation surface 460 can be reinforced with ePTFE. Thecoaptation surface 460 can be reinforced any material of the coaptationassistance element body covering 450, such as ePTFE, Dacron, and/orpolypropylene.

FIG. 47B illustrates the first surface 405. The posterior ventricularcoaption surface can be reinforced. As described herein, the firstsurface 405 can contact a leaflet of the patient. The coaptationassistance element 400, after placement, can entirely cover theposterior leaflet with the first surface 405. The first surface 405 canbe opposite the second surface 415 which includes the coaptation surface460.

In some embodiments, the first surface 405, or a portion thereof, isreinforced. The first surface 405 can be reinforced with one or moreadditional layers. The one or more additional layers can extend over thefirst surface 405 or a portion thereof. The one or more additionallayers can be diametrically opposed to the one or more additional layersthat extend over the second surface 415. The one or more additionallayers can extend over a portion of the first surface 405 opposite thecoaptation surface 460. The one or more additional layers can extendover a portion of the first surface 405 larger than the contact areawith the posterior leaflet.

The first surface 405 can be reinforced with any material describedherein. The first surface 405, or a portion thereof, can be reinforcedwith ePTFE. The first surface 405 can be reinforced with any material ofthe coaptation assistance element body covering 450, such as ePTFE,Dacron, and/or polypropylene, which can advantageously create anatraumatic surface to reduce the risk of native leaflet damage fromrepeated coaptation against the coaptation surface of the coaptationassist body.

FIGS. 47C-47D illustrate an edge of the coaptation assistance element400. As described herein, the coaptation assistance element 400 caninclude a reinforced edge with increased thickness, e.g., the knotlesssutured edge 455. The superior edge 440, the lateral edges 470 and 475,and/or the inferior edge 480 of the coaptation assistance element 400can include a raised edge or bumper. In some embodiments, only one, two,or more edges of the superior edge 440, the lateral edges 470 and 475,or the inferior edge 480 can include a raised edge or bumper. In someembodiments, the raised edge or bumper can comprise Gore-Tex. In someembodiments, the raised edge or bumper is circumferential or at leastpartially circumferential around the peripheral edge of the inferiorzone, or the entire coaptation assist body.

The raised edge or bumper can be formed from a suture. The suture can bewrapped around the edge to form a raised edge or bumper. The raised edgeor bumper may have features, such as increased thickness and/or softnessfor example reduce trauma to the native tissue. The raised edge orbumper can reduce contact between the coaptation assistance element 400and the anatomy of the patient. The raised edge or bumper can reducecontact between the coaptation assistance element 400 and posteriorleaflet, in the case of the mitral valve. In some embodiments, only thefirst surface 405 includes the raised edge. In some embodiments, boththe first surface 405 and the second surface 415 include the raisededge. The raised edge or bumper can be at or near the edge of the firstsurface 405 or the second surface 415. The raised edge or bumper can bespaced inward from the first surface 405 or the second surface 415. FIG.47C illustrates the posterior surface. FIG. 47D illustrates the anteriorsurface.

The raised edge or bumper can include one or more rounded edges thatreduce contact between the coaptation assistance element 400 and theunderlying anatomy of the patient. In some embodiments, contact isreduced between the coaptation assistance element 400 and the posteriorleaflet. In some embodiments, contact is not reduced between thecoaptation assistance element 400 and the annulus. In some embodiments,the coaptation assistance element 400 is configured to minimize contactwith the posterior leaflet but maximize contact with the annulus. Otherconfigurations are contemplated.

FIG. 47E illustrates an anchor zone. The coaptation assistance element400 can include a generally annular superior section 410. The anchorzone can be located within the annular section 410, and can comprise twosections spaced apart from and extending laterally from the hub 420. Theannular section 410 can be positioned relative to the annulus when thecoaptation assistance element 400 is deployed. In some embodiments, theannular section 410 may be curved toward the annulus or curved away fromthe annulus. In other embodiments, the annular section 410 may besubstantially flat with respect to the annulus. The annular section 410can be configured to accept one or more secondary anchors. The secondaryanchors can be advanced over a guide rail which can be coupled to thecoaptation assistance element 400 as described herein. The secondaryanchors can be rotated to penetrate the annular section 410. Thesecondary anchor can engage the tissue disposed under the coaptationassistance element 400.

The annular section 410 such as an anchor zone can be reinforced to havean increased thickness with respect to the rest of the superior zone,and more than, equal to, or less than the thickness of the inferiorcoaptation zone of the implant. The annular section 410 can bereinforced in the area configured to accept one, two, three, four, ormore secondary anchors. As described herein, the first surface 405 ofthe coaptation assistance element 400 can lie against the annulus afterplacement with the heart of the patient. The second surface 415 can faceupward from the annulus. In some embodiments, the annular section 410 ora portion thereof is reinforced. The annular section 410 can bereinforced with one or more additional layers. The one or moreadditional layers can extend over the annular section 410 or a portionthereof. The one or more additional layers can be diametrically opposedrelative to the annular hub 420. The one or more additional layers canextend over a portion of the first surface 405. The one or moreadditional layers can extend over a portion of the second surface 415.The anchor zone can be near the annular hub 420. The anchor zone caninclude one or more separate zones.

The annular section 410 can be reinforced with any material describedherein. The annular section 410, or a portion thereof, can be reinforcedwith ePTFE. The annular section 410, or a portion thereof, can bereinforced with velour. The annular section 410 can be reinforced anymaterial of the coaptation assistance element body covering 450, such asePTFE, Dacron, and/or polypropylene. The one or more additionally layerscan extend outward from the annular hub 420. The one or moreadditionally layers be any shape sufficient to cover an area larger thanthe area engaged by the one or more secondary anchors.

In some embodiments, the annular portion 410 can include a sharper edgethan another edge of the coaptation assistance element 400. In someembodiments, the superior edge 440 is thinner and/or sharper thananother edge of the coaptation assistance element 400 (e.g., the lateraledge 470, the lateral edge 474, or the inferior edge 480). In someembodiments, the annular portion 410 and/or the superior edge 440 can beirritating to or engaging with the tissue. In some embodiments, theannular portion 410 is configured to be implanted near the annulus. Insome embodiments, the annular portion 410 is configured to promote animmune response. In some embodiments, the annular portion 410 isconfigured to promote tissue ingrowth.

FIG. 48 illustrates an exploded view of an embodiment of a coveringsurrounding part of the implant, and includes the laminate. While thecoaptation assistance element 400 is illustrated, any of the coaptationassistance elements described herein can include any number of thefeatures described herein, can exclude/omit any of the features asdescribed herein, or be placed in a different order relative to eachother. In addition, the coaptation assistance element 400 can include orexclude/omit any of the features of the coaptation assistance elementsdescribed herein. The exploded view illustrates the thick reinforcementlayer for the anterior and posterior ventricular portions. The explodedview illustrates the single velour anchor zone. The raised edge orbumper is not shown. The raised edge or bumper can be added in the finalstage of assembly. The laminate 1100 described herein can form thecoaptation assistance element body covering 450. The laminate 1100 caninclude one or more layers as described herein. The laminate 1100 caninclude one or more layers in any order.

The coaptation assistance element 400 can include a posterior layer1102. The posterior layer can form the first surface 405. In someembodiments, the posterior layer 1102 is thin relative to other layers.In some embodiments, the posterior layer 1102 is ePTFE. In someembodiments, the posterior layer 1102 has a thickness (e.g., about0.001″, about 0.0015″, about 0.002″, about 0.0025″, about 0.003″, or anyrange including two of the foregoing values). The posterior layer 1102can include an opening for the anchor 800 to extend there through. Theposterior layer 1102 can be any shape including rectangular, polygonal,triangular, circular, and elliptical. In some embodiments, the posteriorlayer 1102 is not the final shape of the coaptation assistance element400.

The coaptation assistance element 400 can include a first supportingstructure layer 1104. The first supporting structure 1104 can be a mesh.In some embodiments, the first supporting structure layer 1104 comprisesUHMPE. The first supporting structure 1104 can be disposed over theposterior layer 1102. The first supporting structure layer 1104 can bedisposed on the posterior side of the struts 430. The first supportingstructure layer 1104 can include an opening for the anchor 800 to extendthere through.

The coaptation assistance element 400 can include a first fabric layer1106. The first fabric layer 1106 can be relatively thin, and in somecases has a thickness (e.g., about 0.001″, about 0.0015″, about 0.002″,about 0.0025″, about 0.003″, about 0.004″, about 0.005″, about 0.01″ orany range including two of the foregoing values). In some embodiments,the first fabric layer 1106 comprises a polyester fabric. The firstfabric layer 1106 can be disposed over the first supporting structurelayer 1104. The first fabric layer 1106 can be disposed on the posteriorside of the struts 430. The first fabric layer 1106 can include anopening for the anchor 800 to extend there through. In some embodiments,the first fabric layer 1106 extends only along a portion of thecoaptation assistance element 400. In some embodiments, the first fabriclayer 1106 includes a cut out portion.

The coaptation assistance element 400 can include a first ventricularlayer 1108. The ventricular surface layer 1108 can be the reinforcementlayer for the first surface 405. In some embodiments, the firstventricular layer 1108 is thick relative to other layers. In someembodiments, the first ventricular layer 1108 is ePTFE. In someembodiments, the first ventricular layer 1108 has a thickness (e.g.,about 0.01″, 0.02″ 0.03″, about 0.035″, about 0.040″, about 0.045″,about 0.05″, about 0.07″, about 0.10″ or any range including two of theforegoing values). The first ventricular layer 1108 can be any shapeincluding rectangular, polygonal, triangular, circular, elliptical, etc.The first ventricular layer 1108 can be disposed on the posterior sideof the struts 430.

The coaptation assistance element 400 can include an anchor layer 1110.The anchor layer 1110 can be the reinforcement layer for the one or moresecondary anchor. In some embodiments, the anchor layer 1110 is thickrelative to other layers. In some embodiments, the anchor layer 1110 isePTFE. In some embodiments, the anchor layer 1110 is velour. In someembodiments, the anchor layer 1110 has a thickness (e.g., about 0.01″,0.02″, 0.03″, about 0.035″, about 0.040″, about 0.045″, about 0.05″,about 0.07″, about 0.10″ or any range including two of the foregoingvalues). The anchor layer 1110 can be any shape including rectangular,polygonal, triangular, circular, elliptical, etc. In some embodiments,the coaptation assistance element 400 includes a single anchor zonewhich forms the anchor layer 1110. In some embodiments, the coaptationassistance element 400 includes two or more separate anchor zones whichform the anchor layer 1110. The anchor layer 1110 can be disposed on theposterior side of the struts 430 as shown. In the illustrate embodiment,the ventricular surface layer 1108 and the anchor layer 1110 can besandwiched between the same two adjoining layers. In some embodiments,the ventricular surface layer 1108 and the anchor layer 1110 areseparated by one or more layers.

The coaptation assistance element 400 can include a second supportingstructure layer 1112. The second supporting structure layer 1112 can bea mesh. In some embodiments, the second supporting structure layer 1112comprises UHMPE. The second supporting structure layer 1112 can bedisposed over the ventricular surface layer 1108. The second supportingstructure layer 1112 can be disposed on the posterior side of the struts430. In some embodiments, the second supporting structure layer 1112extends only along a portion of the coaptation assistance element 400.In some embodiments, the second supporting structure layer 1112 extendsonly along the ventricular portion of the coaptation assistance element400.

The coaptation assistance element 400 can include a frame 465. In someembodiments, the frame 465 is cut from a tubular stock. The frame 465can include one or more struts 430. The frame 465 can be constructedfrom a single, unitary piece of material. The frame 465 including thestruts 430 thereof can be formed using any method described hereinincluding a water jet, laser etching or similar technology. The detailsof the struts 430, including barbs, can be machined into the struts 430.The frame 465 can be bent and/or shape set to achieve the desiredgeometry. The frame 465 including the struts 430 thereof can comprise aresiliently deformable material such as a shape memory metal, e.g.,Nitinol or a shape memory polymer. In some embodiments, the material isElgiloy. In some embodiments, the frame 465 can comprise of othermaterials including stainless steel, polypropylene, high densitypolyethylene (PE), Dacron, acellular collagen matrix such as SIS, orother plastics, etc. In some embodiments, the struts 430 can includeshape memory material and a strut covering. The strut covering can beany material described herein and can cover the entire strut 430 or aportion thereof. In some embodiments, the struts 430 can compriseNitinol and a LDPE tubing or covering over each strut 430. In someembodiments, the frame 465 can be considered a layer.

The coaptation assistance element 400 can include a second ventricularlayer 1114. The second ventricular layer 1114 can be the reinforcementlayer for the second surface 415. In some embodiments, the secondventricular layer 1114 is thick relative to other layers. In someembodiments, the second ventricular layer 1114 is ePTFE. In someembodiments, the second ventricular layer 1114 has a thickness (e.g.,about 0.03″, about 0.035″, about 0.040″, about 0.045″, about 0.05″, orany range including two of the foregoing values or other thicknessvalues as described with respect to other layers herein). secondventricular layer 1114 can be any shape including rectangular,polygonal, triangular, circular, elliptical, etc. The second ventricularlayer 1114 can be disposed on the anterior side of the struts 430. Insome embodiments, the second ventricular layer 1114 extends only along aportion of the coaptation assistance element 400. In some embodiments,the second ventricular layer 1114 extends only along the ventricularportion of the coaptation assistance element 400. In some embodiments,the first ventricular layer 1108 and second ventricular layer 1114 arethe same shape.

The coaptation assistance element 400 can include a third supportingstructure layer 1116. The a third supporting structure layer 1116 can bea mesh. In some embodiments, the a third supporting structure layer 1116can comprise UHMPE. The third supporting structure layer 1116 can bedisposed over the second ventricular layer 1114. The third supportingstructure layer 1116 can be disposed on the anterior side of the struts430. In some embodiments, the third supporting structure layer 1116extends only along a portion of the coaptation assistance element 400.In some embodiments, the third supporting structure layer 1116 extendsonly along the ventricular portion of the coaptation assistance element400.

The coaptation assistance element 400 can include a second fabric layer1118. The second fabric layer 1118 can be thin relative to other layers.In some embodiments, the second fabric layer 1118 has a thickness (e.g.,about 0.001″, about 0.0015″, about 0.002″, about 0.0025″, about 0.003″,or any range including two of the foregoing values). In someembodiments, the second fabric layer 1118 comprises a polyester fabric.The second fabric layer 1118 can be disposed over the third supportingstructure layer 1116. The second fabric layer 1118 can be disposed onthe anterior side of the struts 430. The second fabric layer 1118 caninclude an opening for the anchor 800 to extend there through.

The coaptation assistance element 400 can include a fourth supportingstructure layer 1120. The fourth supporting structure layer 1120 can bea mesh. In some embodiments, the fourth supporting structure layer 1120can comprise UHMPE. The fourth supporting structure layer 1120 can bedisposed over the second fabric layer 1118. The fourth supportingstructure layer 1120 can be disposed on the anterior side of the struts430. The fourth supporting structure layer 1120 can include an openingfor the anchor 800 to extend there through. In some embodiments, thefirst supporting structure layer 1104 and the fourth supportingstructure layer 1120 are the same shape.

The coaptation assistance element 400 can include an anterior layer1122. The anterior layer 1122 can form the second surface 415. In someembodiments, the anterior layer 1122 is thin relative to other layers.In some embodiments, the anterior layer 1122 is ePTFE. In someembodiments, the anterior layer 1122 has a thickness (e.g., about0.001″, about 0.0015″, about 0.002″, about 0.0025″, about 0.003″, or anyrange including two of the foregoing values, or other thickness valuesas described with respect to other layers herein). The anterior layer1122 can include an opening for the anchor 800 to extend there through.The anterior layer 1122 can be any shape including rectangular,polygonal, triangular, circular, and elliptical. In some embodiments,the anterior layer 1122 is not the final shape of the coaptationassistance element 400. In some embodiments, the posterior layer 1102and the anterior layer 1122 are the same shape.

FIG. 49 illustrate an embodiment of implant delivery system 2200. Theimplant delivery system 2200 can include any of the features of implantdelivery systems described herein. The implant delivery system 2200 caninclude a primary anchor housing 2202. In some embodiments, the primaryanchor housing 2202 is a docking tube. The primary anchor housing 2202can be cylindrical. The primary anchor housing 2202 can include acentral lumen. The primary anchor housing 2202 can be disposed aroundthe annular hub 420, 520, 620, 720 of the coaptation assistance element400, 500, 600, 700.

The implant delivery system 2200 can include a primary anchor driver2204. The primary anchor housing 2202 can be dimensioned to fit theprimary anchor driver 2204. In some embodiments, the primary anchordriver 2204 is a torque shaft. In some embodiments, the primary anchordriver 2204 is configured to rotate relative to the primary anchorhousing 2202. In some embodiments, the primary anchor driver 2204 is notconfigured to translate relative to the primary anchor housing 2202. Theprimary anchor driver 2204 can be considered a primary anchor forkdriver, as described herein. The primary anchor driver 2204 can designedto engage and rotate the anchor 800. The anchor 800 can be considered aprimary anchor 800 to distinguish from one or more secondary anchors.

The implant delivery system 2200 can include one or more release wires2206, 2208. In the illustrated embodiment, the implant delivery system2200 can include two release wires 2206, 2208, but other configurationsare contemplated (e.g., one release wire, two release wires, threerelease wires, four release wires, five release wires, six releasewires, etc.). The release wires 2206, 2208 can extend proximally fromthe primary anchor housing 2202. In some embodiments, the release wires2206, 2208 can extend beyond the implant surface. The release wires2206, 2208 can extend through at least a portion of the primary anchorhousing 2202. The release wires 2206, 2208 can extend through one ormore channels or tubes within the primary anchor housing 2202. Therelease wires 2206, 2208 can be diametrically opposed within the primaryanchor housing 2202.

The release wires 2206, 2208 can extend outside of the primary anchorhousing 2202. The primary anchor housing 2202 can include slots 2210,2212 that allow the release wires 2206, 2208 to extend there through.The release wires 2206, 2208 can extend from inside the primary anchorhousing 2202 to outside of the primary anchor housing 2202 through theslots 2210, 2212 (e.g., the release wire 2206 can extend through slot2210, the release wire 2208 can extend through slot 2212).

The release wires 2206, 2208 can extend back inside the primary anchorhousing 2202. The primary anchor housing 2202 can include slots 2214,2216 that allow the release wires 2206, 2208 to extend there through.The release wires 2206, 2208 can extend from outside the primary anchorhousing 2202 to inside of the primary anchor housing 2202 through theslots 2214, 2216 (e.g., the release wire 2206 can extend through slot2214, the release wire 2208 can extend through slot 2216). The releasewires 2206, 2208 can weave in and out of the primary anchor housing2202. The release wires 2206, 2208 can couple to the primary anchorhousing 2202. The release wires 2206, 2208 can extend through the anchor800. The release wires 2206, 2208 can cross.

The release wires 2206, 2208 can extend along the coaptation assistanceelement 400, 500, 600, 700. The release wires 2206, 2208 can extendalong the annular surface 410, 510, 610, 710. The release wires 2206,2208 can extend underneath the coaptation assistance element 400, 500,600, 700. The release wires 2206, 2208 can extend in oppositedirections. The release wires 2206, 2208 can be diametrically opposed.The release wires 2206, 2208 can be coaxial. The release wires 2206,2208 can be generally along a line. The release wires 2206, 2208 can beadjacent to the annulus. The release wires 2206, 2208 can contact theannulus. The release wires 2206, 2208 can facilitate coupling betweenthe implant delivery system 2200 and the coaptation assistance element400, 500, 600, 700. The release wires 2206, 2208 can rigidly hold theprimary anchor housing 2202 against the annular hub 420, 520, 620, 720of the coaptation assistance element 400, 500, 600, 700. The releasewires 2206, 2208 can extend from the anterior side to the posterior sideof the coaptation assistance element 400, 500, 600, 700. In someembodiments, the ends of the release wires 2206, 2208 wrap around thecoaptation assistance element 400, 500, 600, 700. In some embodiments,the ends of the release wires 2206, 2208 are curved or form a c-shapedconfiguration.

The implant delivery system 2200 can include one or more secondaryanchors 2220, 2222, 2224, 2226 (e.g., one secondary anchor, twosecondary anchors, three secondary anchors, four secondary anchors (asshown), five secondary anchors, six secondary anchors, seven secondaryanchors, eight secondary anchors, etc.). In some embodiments, two ormore secondary anchors 2220, 2222, 2224, 2226 are the same. In someembodiments, two or more secondary anchors 2220, 2222, 2224, 2226 aredifferent (e.g., different pitch, different diameter, differentmaterial, different shoulder, different window, etc.). In someembodiments, the secondary anchor 2220, 2222, 2224, 2226 can be helicalanchors. The secondary anchor 2220, 2222, 2224, 2226 can have a smallerdiameter than the primary anchor 800. The secondary anchor 2220, 2222,2224, 2226 can have a smaller pitch than the primary anchor 800. Thesecondary anchor 2220, 2222, 2224, 2226 can be configured to rotate toengage tissue in the annulus.

The implant delivery system 2200 can include one or more secondaryanchor drivers 2230, 2232, 2234, 2236 (e.g., one secondary anchordriver, two secondary anchor drivers, three secondary anchor drivers,four secondary anchor drivers (as shown), five secondary anchor drivers,six secondary anchor drivers, seven secondary anchor drivers, eightsecondary anchor drivers, etc.). In some embodiments, two or moresecondary anchor drivers 2230, 2232, 2234, 2236 are the same. In someembodiments, two or more secondary anchor drivers 2230, 2232, 2234, 2236are different (e.g., different configuration, mirror image, differentanchor coupled therewith, etc.). In some embodiments, the secondaryanchor driver 2230, 2232, 2234, 2236 is a torque shaft. In someembodiments, the secondary anchor driver 2230, 2232, 2234, 2236 isconfigured to rotate the respective secondary anchor 2220, 2222, 2224,2226. In some embodiments, the secondary anchor driver 2230, 2232, 2234,2236 is configured to translate the respective secondary anchor 2220,2222, 2224, 2226.

In some embodiments, the secondary anchor driver 2230, 2232, 2234, 2236can be coupled to the respective secondary anchor 2220, 2222, 2224, 2226according to any embodiment described herein. In some embodiments, eachsecondary anchor drivers 2230, 2232, 2234, 2236 couples to a respectivesecondary anchor 2220, 2222, 2224, 2226. In some embodiments, eachsecondary anchor drivers 2230, 2232, 2234, 2236 couples to two or moresecondary anchors 2220, 2222, 2224, 2226. In some embodiments, a singlesecondary anchor driver, for example 2230, couples to all of thesecondary anchors 2220, 2222, 2224, 2226.

The implant delivery system 2200 can include one or more secondaryanchor guide rails 2240, 2242, 2244, 2246 (e.g., one secondary anchorguide rail, two secondary anchor guide rails, three secondary anchorguide rails, four secondary anchor guide rails (as shown), fivesecondary anchor guide rails, six secondary anchor guide rails, sevensecondary anchor guide rails, eight secondary anchor guide rails, etc.).The number of secondary anchor guide rails 2240, 2242, 2244, 2246 cancorrespond to the number of secondary anchors 2220, 2222, 2224, 2226.The secondary anchor 2220, 2222, 2224, 2226 can include a passagewaythere through. The passageway can extend through the middle of thehelical wire of the secondary anchor 2220, 2222, 2224, 2226. Thesecondary anchor guide rail 2240, 2242, 2244, 2246 can be configured toextend through the respective passageway.

The implant delivery system 2200 can include one or more secondaryanchor tethers 2250, 2252, 2254, 2256 (e.g., one secondary anchortether, two secondary anchor tethers, three secondary anchor tethers,four secondary anchor tethers (as shown), five secondary anchor tethers,six secondary anchor tethers, seven secondary anchor tethers, eightsecondary anchor tethers, etc.). The number of secondary anchor tethers2250, 2252, 2254, 2256 can correspond to the number of secondary anchors2220, 2222, 2224, 2226. The secondary anchor tethers 2250, 2252, 2254,2256 can form a loop. Each secondary anchor tether 2250, 2252, 2254,2256 can include a first strand, a second strand, and an arc therebetween. Each secondary anchor tether 2250, 2252, 2254, 2256 can looparound a respective release wire 2206, 2208 as described herein. Thesecondary anchor tethers 2250, 2252, 2254, 2256 can extend through thecoaptation assistance element 400, 500, 600, 700. The coaptationassistance element 400, 500, 600, 700 can include one or morepassageways to facilitate passage of the secondary anchor tether 2250,2252, 2254, 2256 there through.

The secondary anchor guide rails 2240, 2242, 2244, 2246 can include apassageway there through. The passageway can extend through the middleof the secondary anchor guide rails 2240, 2242, 2244, 2246. Thesecondary anchor tethers 2250, 2252, 2254, 2256 can be configured toextend through the passageway of the secondary anchor guide rails 2240,2242, 2244, 2246. In some embodiments, each secondary anchor tethers2250, 2252, 2254, 2256 extends through a respective secondary anchorguide rails 2240, 2242, 2244, 2246. The secondary anchor drivers 2230,2232, 2234, 2236 can include a passageway there through. The passagewaycan extend through the middle of the secondary anchor drivers 2230,2232, 2234, 2236. The secondary anchor tethers 2250, 2252, 2254, 2256can be configured to extend through the passageway of the secondaryanchor drivers 2230, 2232, 2234, 2236.

The release wires 2206, 2208 can maintain the connection to thecoaptation assistance element 400, 500, 600, 700. The release wires2206, 2208 can maintain the connection between the coaptation assistanceelement 400, 500, 600, 700 and the primary anchor 800. The release wires2206, 2208 can maintain the connection between the coaptation assistanceelement 400, 500, 600, 700 and the primary anchor driver 2204. Therelease wires 2206, 2208 can maintain the connection between thecoaptation assistance element 400, 500, 600, 700 and the secondaryanchor tethers 2250, 2252, 2254, 2256.

FIG. 50 illustrates the telescoping action to access the primary anchorlocation according to some embodiments of the invention. The primaryanchor 800 can be positioned near the leaflets. The primary anchor 800can be positioned near the annulus. In some methods, access is achievedwith the transseptal sheath 1400. The transseptal sheath 1400 caninclude a lumen for the passage of one or more additional catheters. Thecoaptation assistance element 400, 500, 600, 700 described herein can bedelivered via a delivery catheter 1402. The coaptation assistanceelement 400, 500, 600, 700 can be within the delivery catheter 1402. Thedelivery catheter 1402 can telescope relative to the transseptal sheath1400. The delivery catheter 1402 can telescope relative to thetransseptal sheath 1400 to extend outward relative to the transseptalsheath 1400 for delivery of the coaptation assistance element 400, 500,600, 700. The coaptation assistance element 400, 500, 600, 700 cantelescope relative to the delivery catheter 1402 to extend outwardrelative to the delivery catheter 1402 for delivery of the coaptationassistance element 400, 500, 600, 700.

FIG. 51 illustrates the rotation of the primary anchor driver 2204according to some embodiments of the invention. FIG. 51 illustrates aprogression of engaging the primary anchor 800. On the left, the initialposition of the primary anchor driver 2204 and the primary anchor 800are illustrated. The primary anchor 800 can be proximal the tissue in aproximal position. In the middle, the primary anchor driver 2204 isrotated to rotate the primary anchor 800. The primary anchor 800 rotatesand translates relative to the primary anchor driver 2204. The primaryanchor 800 engages the tissue. On the right, the primary anchor 800 isfurther rotated to engage tissue. The primary anchor 800 can bereversible. The primary anchor 800 can be rotated in one direction toengage tissue, and rotated in a second, opposite direction to disengagetissue.

The primary anchor driver 2204 can engage and rotate the primary anchor800. The primary anchor driver 2204 can be disposed within the primaryanchor housing 2202. The primary anchor 800 can be disposed within theprimary anchor housing 2202. The release wires 2206, 2208 can extendthrough at least a portion of the primary anchor housing 2202. As theprimary anchor 800 is rotates, the helixes of the primary anchor passaround the release wires 2206, 2208. The release wires 2206, 2208maintain their position as the primary anchor 800 rotates. The primaryanchor 800 can be advanced to engage tissue when the coaptationassistance element 400, 500, 600, 700 is adjacent to the annulus. Theprimary anchor driver 2204 can include a hub 2260 and one or moreextensions 2262, 2264. The primary anchor driver 2204 can include twoextensions 2262, 2264, but other configurations are contemplated. Theextensions 2262, 2264 can be perpendicular to the hub 2560 or extend atother angles. The primary anchor driver 2204 can be a fork driver. Theprimary anchor 800 can include a cross-bar 802. The cross-bar 802 canform the proximal part of the primary anchor 800. The cross-bar 802 canbe formed from a helix of the helical anchor. The two extensions 2262,2264 can be configured to slide within the passageway of the primaryanchor 800 on either side of the cross-bar 802. The cross-bar 802 can bedisposed between the extensions 2262, 2264. Other configurations ofcoupling the primary anchor driver 2204 to the primary anchor 800 arecontemplated including any of the mating configurations describedherein.

In some embodiments, the primary anchor driver 2204 rotates but does notmove in the axial direction. In some embodiments, the primary anchordriver 2204 rotates but does not translate relative to the primaryanchor housing 2202. The fork of the primary anchor driver 2204 rotatesto drive the primary anchor 800. In some embodiments, the primary anchordriver 2204 does not advance axially. In some embodiments, the primaryanchor driver 2204 is retained within the primary anchor housing 2202.In some embodiments, an advantage is to limit translation of the primaryanchor driver 2204. The limit related to axial movement of the primaryanchor driver 2204 can reduce or prevent inadvertent interaction of theprimary anchor driver 2204 with the tissue. The limit related to axialmovement of the primary anchor driver 2204 can reduce or preventinadvertent interaction of the primary anchor driver 2204 with therelease wires 2206, 2208.

FIG. 52 illustrates the connection between the secondary anchor driver2230 and the respective secondary anchor 2220 according to someembodiments. While the secondary anchor driver 2230 and the secondaryanchor 2220 are illustrated, each secondary anchor drivers 2230, 2232,2234, 2236 can couple to a respective secondary anchor 2220, 2222, 2224,2226.

The secondary anchor 2220 can include a helical body 2270. The secondaryanchor 2220 can include a shoulder 2272. The shoulder 2272 can beconfigured to engage the secondary anchor driver 2230. The shoulder 2272can have features such as one or more windows 2274. The windows 2274 canbe diametrically opposed, equally spaced, or otherwise spaced apart.While two windows 2274 are shown, other configurations of windows arecontemplated (e.g., one window, two windows (shown), three windows, fourwindows, five windows, six windows, etc.).

The secondary anchor driver 2230 can include an elongated shaft 2276.The elongated shaft can include a lumen for passage of the secondaryanchor guide rail 2240 there through. The secondary anchor driver 2230can include one or more locking tabs 2278. The locking tabs 2278 can bediametrically opposed, equally spaced, or otherwise spaced apart. Whiletwo locking tabs 2278 are shown, other configurations of locking tabsare contemplated (e.g., one locking tab, two locking tabs (shown), threelocking tabs, four locking tabs, five locking tabs, six locking tabs,etc.). The number and configuration of the locking tabs can correspondto the number of windows. The locking tabs 2278 can include a shapememory or springy material. The locking tabs 2278 can be designed toflex outward into engagement with the windows 2274.

The secondary anchor guide rail 2240 can activate the lock mechanismbetween the secondary anchor driver 2230 and the respective secondaryanchor 2220. The lock mechanism can be an axial-torsional lock. Oncecoupled, the axial movement of the secondary anchor driver 2230 cancause axial movement of the secondary anchor 2220. Once coupled, thetorsional movement of the secondary anchor driver 2230 can causetorsional movement of the secondary anchor 2220. The secondary anchorguide rail 2240 can lock the secondary anchor driver 2230 to thesecondary anchor 2220. This lock can be temporary. This lock can bereversible. The secondary anchor guide rail 2240 can push outward thelocking tabs 2278. The locking tabs 2278 can be pushed outward into thewindows 2274 by the secondary anchor guide rail 2240.

The secondary anchor guide rail 2240 can maintain the locking tabs 2278in the open position to keep the locking tabs 2278 engaged with thewindows 2274 in the secondary anchor 2230. In some embodiments, thelongitudinal movement of the secondary anchor guide rail 2240 toward thesecondary anchor 2220 can push the locking tabs 2278 outward toward thewindows 2274. In some embodiments, the longitudinal movement of thesecondary anchor guide rail 2240 away from the secondary anchor 2220 canallow the locking tabs 2278 to regain a neutral configuration anddisengage from the windows 2274. The locking tabs 2278 engaged with thewindows 2274 of the secondary anchor 2220 can allow the transmission ofaxial movement between the secondary anchor driver 2230 and thesecondary anchor 2220. The locking tabs 2278 engaged with the windows2274 of the secondary anchor 2220 can allow the transmission of torquebetween the secondary anchor driver 2230 and the secondary anchor 2220.In some embodiments, an advantage is the secondary anchor 2220 can berotated independently of the rotation of the primary anchor 800. In someembodiments, an advantage is the secondary anchor 2220 can be rotatedindependently of the rotation of one or more other secondary anchors2232, 2234, 2236.

FIGS. 53A-53B illustrates the relationship between the secondary anchorguide rail 2240, secondary anchor tether 2250, and the respectivesecondary anchor 2220 according to some embodiments. While the secondaryanchor guide rail 2240, secondary anchor tether 2250, and the secondaryanchor 2220 are illustrated, each secondary anchor guide rail 2240,2242, 2244, 2246 can engage a respective secondary anchor 2220, 2222,2224, 2226. The secondary anchor guide rail 2240 can limit or preventanchor and tether engagement. FIGS. 53A-53B illustrate the secondaryanchor tether 2250 and an adjacent secondary anchor tether 2252. Eachsecondary anchor tether can include two strands and an arc therebetween, see secondary anchor tether 2252.

The secondary anchor 2220 can be a helical anchor. The helical anchorcan include a pitch and a diameter. The helical anchor can include anopen distal end. The pitch of the secondary anchor 2220 can be largerthan a strand of the secondary anchor tether (e.g., secondary anchortether 2252). The open end of the secondary anchor 2220 can be largerthan a strand of the secondary anchor tether (e.g., secondary anchortether 2252). The dimension of the open end can be defined by the pitch.This configuration may allow the secondary anchor 2220 and the secondaryanchor tether 2252 to become tangled as shown in FIG. 53A. In thisfigure, the secondary anchor tether 2252 and the secondary anchor 2220can become entangled because the secondary anchor guide rail 2240 isproximal, exposing the open end of the secondary anchor 2220.

FIG. 53B illustrates the secondary anchor guide rail 2240 extendingthrough the open end of the pitch the secondary anchor 2220, accordingto some embodiments of the invention. The pitch of the secondary anchor2220 can be smaller than a strand of the secondary anchor tether (e.g.,secondary anchor tether 2252). The open end of the secondary anchor 2220can be smaller than a strand of the secondary anchor tether (e.g.,secondary anchor tether 2252). The space between the secondary anchorguide rail 2240 and the secondary anchor 2220 can be advantageously toosmall to allow the entanglement of the secondary anchor tether 2252.This configuration may prevent the secondary anchor 2220 and thesecondary anchor tether 2252 from becoming tangled. In FIG. 53B, theopen end of the secondary anchor is protected from entanglement.

FIG. 54 illustrates the secondary anchor guide rail 2240, according tosome embodiments of the invention. While the secondary anchor guide rail2240 is illustrated, one or more secondary anchor guide rails 2240,2242, 2244, 2246 can be deployed. The secondary anchor guide rail 2240,2242, 2244, 2246 can include a pre-shaped material. The secondary anchorguide rail 2240, 2242, 2244, 2246 can include a shape memory materialsuch as a shape memory metal or plastic. The secondary anchor guide rail2240, 2242, 2244, 2246 can include any shape including one or morelinear segments and one or more non-linear segments such as one or morecurved segments. The pre-shape of the secondary anchor guide rail 2240,2242, 2244, 2246 can facilitate the trajectory for the respectivesecondary anchor 2220, 2222, 2224, 2226. The pre-shaped distal end ofthe secondary anchor guide rail 2240, 2242, 2244, 2246 can influence theanchoring trajectory for the secondary anchor 2220. In FIG. 54 , thesecondary anchor guide rail 2240 is pre-shaped to include a distalcurve. The secondary anchor guide rail 2240 is shown in two differentorientations. The orientation of the secondary anchor guide rail 2240can allow the ability to define different secondary anchor trajectories.In some embodiments, two or more trajectories can be defined bysecondary anchor guide rail 2240.

FIGS. 55A-55C illustrates the proximal assembly for secondary anchors,according to some embodiments of the invention. The proximal assemblycan include one or more guide rail locks. The secondary anchor guiderails 2240, 2242, 2244, 2246 can be locked to limit or prevent axialmovement. Locking of the secondary anchor guide rails 2240, 2242, 2244,2246 can ensure that the secondary anchor guide rails 2240, 2242, 2244,2246 will be distal to the secondary anchor 2220, 2222, 2224, 2226, seeFIG. 53B. The secondary anchor guide rails 2240, 2242, 2244, 2246 can belocked in a position wherein at least a portion is distal to the openend of the secondary anchor 2220, 2222, 2224, 2226. The secondary anchorguide rails 2240, 2242, 2244, 2246 can be locked to ensure that thesecondary anchor 2220, 2222, 2224, 2226 does not become entangled withthe secondary anchor tethers 2250, 2252, 2254, 2256. The secondaryanchor guide rails 2240, 2242, 2244, 2246 can be locked to ensure thatthe secondary anchor 2220, 2222, 2224, 2226 remains coupled to arespective secondary anchor drivers 2230, 2232, 2234, 2236. Thesecondary anchor guide rails 2240, 2242, 2244, 2246 can be locked toensure that the secondary anchor 2220, 2222, 2224, 2226 does not becomeprematurely released.

The proximal assembly can include one or more tether locks. Thesecondary anchor tethers 2250, 2252, 2254, 2256 can be locked to ensureappropriate tension is maintained. In some embodiments, applyingappropriate tension to the secondary anchor tethers 2250, 2252, 2254,2256 defines the desired trajectory for the secondary anchor 2220, 2222,2224, 2226. Locking the secondary anchor tethers 2250, 2252, 2254, 2256after tension is applied can ensure that the tension is reliablymaintained during the delivery of the secondary anchor 2220, 2222, 2224,2226.

FIG. 55A illustrates the proximal assembly coupled to the secondaryanchor driver 2230. While secondary anchor driver 2230 is illustrated,each secondary anchor driver 2230, 2232, 2234, 2236 can be coupled to aproximal assembly. In some embodiments, two or more secondary anchordrivers 2230, 2232, 2234, 2236 can be coupled to the same proximalassembly in order to lock two or more respective secondary anchor guiderails or two or more respective secondary anchor tethers. The proximalassembly can include the secondary anchor guide rail lock 2280. Theproximal assembly can include the secondary anchor tether lock 2282.FIG. 55B illustrates the secondary anchor guide rail lock 2280 in alocked position wherein the secondary anchor guide rails 2240 isprevented or limited from moving proximally. The secondary anchor guiderail lock 2280 can include a threaded bolt configured to engage athreaded nut. The secondary anchor guide rail lock 2280 can limitproximal motion by functioning as a stop when locked. The secondaryanchor guide rail lock 2280 can allow proximal motion when unlocked. Insome embodiments, the secondary anchor guide rails 2240 can be removedin the unlocked position. The secondary anchor guide rails 2240 can beremoved to release the secondary anchor driver 2230 from the secondaryanchor 2220.

FIG. 55C illustrates the secondary anchor tether lock 2282 in anunlocked position wherein the secondary anchor tether 2250 can moveproximally. The secondary anchor tether lock 2282 can include a threadedbolt configured to engage a threaded nut. The secondary anchor tetherlock 2282 can limit any proximal motion by functioning as a stop whenlocked. In some embodiments, the secondary anchor tether 2250 can beremoved in the unlocked position. The secondary anchor tether 2250 canbe removed after the secondary anchor 2220 is delivered. The secondaryanchor tether 2250 can be pulled from outside of the body of thepatient. The secondary anchor tether 2250 can allow the user to performa suture count.

FIG. 56 illustrates an anti-rotation feature on the secondary anchor2220, 2222, 2224, 2226. The secondary anchor 2220 can include theshoulder 2272. The shoulder 2272 can be configured to engage thesecondary anchor driver 2230 as described herein. The shoulder 2272 canhave features such as one or more anti-rotation features 2284. Theanti-rotation feature 2284 can include one or more barbs configured toengage tissue. While one anti-rotation feature 2284 is shown, otherconfigurations of anti-rotation features are contemplated (e.g., oneanti-rotation feature (shown), two anti-rotation features, threeanti-rotation features, four anti-rotation features, five anti-rotationfeatures, six anti-rotation features, etc.). Two or more anti-rotationfeatures 2284 can be diametrically opposed, equally spaced, or otherwisespaced apart. In some embodiments, the anti-rotation feature 2284prevents further rotation of the secondary anchor 2220, 2222, 2224,2226. In some embodiments, the secondary anchor 2220, 2222, 2224, 2226is configured for left-handed rotation. In some embodiments, thesecondary anchor 2220, 2222, 2224, 2226 is configured for right-handedrotation. In some embodiments, the anti-rotation feature 2284 isconfigured for reduce or limit left-handed rotation. In someembodiments, the anti-rotation feature 2284 is configured for reduce orlimit right-handed rotation.

FIG. 57 illustrates posterior leaflet augmentation and restoration indiastole. FIG. 57 illustrates posterior leaflet augmentation andrestoration in systole.

Referring back to FIG. 49 , the coaptation assistance element 400, 500,600, 700 can be delivered to the valve annulus. The primary anchor 800can be disposed within the primary anchor housing 2202. The primaryanchor driver 2204 can be disposed within the primary anchor housing2202. The one or more release wires 2206, 2208 can engage the primaryanchor housing 2202. The release wires 2206, 2208 can engage the primaryanchor 800. The release wires 2206, 2208 can be disposed on the annularside of the coaptation assistance element 400, 500, 600, 700. Thesecondary anchor tethers 2250, 2252, 2254, 2256 can extend through thecoaptation assistance element 400, 500, 600, 700. The secondary anchortethers 2250, 2252, 2254, 2256 can form a loop around the release wires2206, 2208. The secondary anchor tethers 2250, 2252, 2254, 2256 canextend proximally. The secondary anchor tethers 2250, 2252 can extendaround release wire 2208. The secondary anchor tethers 2250, 2252 can bespaced apart along the release wire 2208. The secondary anchor tethers2254, 2256 can extend around release wire 2206. The secondary anchortethers 2254, 2256 can be spaced apart along the release wire 2206.

The coaptation assistance element 400, 500, 600, 700 can be delivered ina low profile configuration. The coaptation assistance element 400, 500,600, 700 can rolled, compressed, folded, or otherwise reduced in sizefor delivery. In some embodiments, the release wires 2206, 2208 help tomaintain the position of the primary anchor driver 2204 relative to thecoaptation assistance element 400, 500, 600, 700. In some embodiments,the release wires 2206, 2208 help to maintain the position of theprimary anchor 800 relative to the coaptation assistance element 400,500, 600, 700. In some embodiments, the release wires 2206, 2208 help tomaintain the position of the secondary anchor tethers 2250, 2252, 2254,2256 relative to the coaptation assistance element 400, 500, 600, 700.In some embodiments, the ends of the release wires 2206, 2208 wraparound the coaptation assistance element 400, 500, 600, 700 to maintainthe position of the release wires 2206, 2208 relative to the coaptationassistance element 400, 500, 600, 700.

The coaptation assistance element 400, 500, 600, 700 can be deliveredvia the delivery catheter 1402 as shown in FIG. 50 . The telescopingaction can position the coaptation assistance element 400, 500, 600, 700relative to a location to engage the primary anchor 800 with tissue. Thecoaptation assistance element 400, 500, 600, 700 can be expanded, orpartially expanded within the heart valve.

The primary anchor 800 can be rotated to engage tissue as shown in FIG.51 . The primary anchor driver 2204 can rotate to rotate the primaryanchor 800. The primary anchor driver 2204 can rotate, but in someembodiments, does not translate. The primary anchor driver 2204 canengage the cross-bar 802 of the primary anchor 800. The primary anchordriver 2204 can include forked configuration to engage either side ofthe cross-bar 802. The primary anchor 800 can be removed by rotating theprimary anchor driver 2204 in the opposite direction. The coaptationassistance element 400, 500, 600, 700 can be functionally tested priorto engaging one or more secondary anchors 2220, 2222, 2224, 2226. Insome embodiments, only the primary anchor 800 is utilized. In someembodiments, only one or more secondary anchors 2220, 2222, 2224, 2226are utilized. In some embodiments, one or more secondary anchors 2220,2222, 2224, 2226 engage tissue after the primary anchor 800 engagestissue.

Referring back to FIG. 49 , in some methods, the secondary anchorassembly is moved toward the annulus. The secondary anchor drivers 2230,2232, 2234, 2236 can engage a respective secondary anchor 2220, 2222,2224, 2226. Referring to FIG. 52 , the secondary anchor guide rails2240, 2242, 2244, 2246 can maintain the engagement between the secondaryanchor drivers 2230, 2232, 2234, 2236 and the respective secondaryanchors 2220, 2222, 2224, 2226. The secondary anchor guide rails 2240,2242, 2244, 2246 can keep the locking tabs 2278 engaged with the windows2274. Referring to FIG. 53 , the secondary anchor guide rails 2240,2242, 2244, 2246 can extend beyond the open end of the secondary anchor2220, 2222, 2224, 2226. The secondary anchor guide rail 2240, 2242,2244, 2246 can prevent entanglement between the secondary anchor 2220,2222, 2224, 2226 and an adjacent tether. Referring to FIG. 55B, theguide rail lock 2280 can reduce or prevent proximal movement of thesecondary anchor guide rails 2240, 2242, 2244, 2246.

FIG. 48 illustrates the delivery of the secondary anchor 2224. Thesecondary anchor driver 2234 can be coupled with the secondary anchor2224. The secondary anchor guide rail 2244 can extend beyond the openend of the secondary anchor 2224. The secondary anchor guide rail 2244can facilitate the coupling between the secondary anchor driver 2234 andthe secondary anchor 2224. The secondary anchor guide rail 2244 canreduce or prevent tangling between the secondary anchor 2224 and theadjacent secondary anchor tethers 2256. The secondary anchor guide rail2244 can slide along the secondary anchor tethers 2254 toward theannulus. The secondary anchor guide rail 2244 can be partially retractedwhen the secondary anchor 2224 is near the coaptation assistance element400, 500, 600, 700. The secondary anchor guide rail 2244 can facilitatethe coupling between the secondary anchor driver 2234 and the secondaryanchor 2224 when partially retracted. The secondary anchor guide rail2244 can be partially retracted along the helical length of thesecondary anchor 2224, however, the secondary anchor guide rail 2244 canstill be positioned to interact with the locking tabs 2278 (see positionin FIG. 52 ).

The secondary anchor driver 2234 can rotate to engage the secondaryanchor 2224 with tissue. The secondary anchor 2224 can penetrate thecoaptation assistance element 400, 500, 600, 700. The secondary anchor2224 can include one or more anti-rotation feature 2284. The secondaryanchor 2224 can be rotated until the anti-rotation feature 2284 isadjacent or engages tissue. The secondary anchor 2224 can be rotateduntil the anti-rotation feature 2284 is adjacent or engages thecoaptation assistance element 400, 500, 600, 700.

After deploying the secondary anchor 2224, the secondary anchor guiderail 2244 can be removed which can allow the secondary anchor driver2234 to decouple from the secondary anchor 2224. The secondary anchordriver 2234 can be removed. The anchor tether 2254 can be removed bypulling on an extracorporeal end of a strand of the tether 2254. Thesecondary anchors 2220, 2222, 2224, 2226 can be similarly deployed usingthe respective secondary anchor drivers 2230, 2232, 2234, 2236,secondary anchor guide rails 2240, 2242, 2244, 2246, and secondaryanchor tethers 2250, 2252, 2254, 2256. The secondary anchors 2220, 2222,2224, 2226 can be independently rotated to engage tissue. The secondaryanchors 2220, 2222, 2224, 2226 can be simultaneously rotated to engagetissue. The secondary anchors 2220, 2222, 2224, 2226 can be sequentiallyrotated to engage tissue.

After deployment of the primary anchor 800 and/or one or more secondaryanchors 2220, 2222, 2224, 2226, the release wires 2206, 2208 can beremoved. The release wires 2206, 2208 can be removed by pulling on theextracorporeal end of the release wire 2206, 2208. The primary anchorhousing 2202 can be removed with the primary anchor driver 2204 disposedtherein.

FIGS. 58A-58J illustrate an embodiment of an implant delivery system2300. The implant delivery system 2300 can include any of the featuresof implant delivery systems described herein. The implant deliverysystem 2300 can include features of implant delivery system 2200 andsimilar references numbers are used herein.

Referring to FIG. 58A, the telescoping action to access the primaryanchor location according to some embodiments is illustrated. In somemethods, access is achieved with the transseptal sheath 1400. Thetransseptal puncture 1404 through the atrial septum, e.g., fossa ovalis,is shown for reference. The transseptal sheath 1400 can include a lumenfor the passage of one or more additional catheters. The coaptationassistance element 400, 500, 600, 700 described herein can be deliveredvia a delivery catheter (not shown in FIG. 58A). The delivery cathetercan telescope relative to the transseptal sheath 1400 to extend outwardrelative to the transseptal sheath 1400 for delivery of the coaptationassistance element 400, 500, 600, 700. The coaptation assistance element400, 500, 600, 700 can include a frame, e.g., 465, 565.

The implant delivery system 2300 can include a primary anchor housing2302. The primary anchor housing 2302 can be disposed around the annularhub 420, 520, 620, 720 of the coaptation assistance element 400, 500,600, 700 illustrated in FIG. 58B. The implant delivery system 2300 caninclude a primary anchor driver 2304 illustrated in FIG. 58B. Theprimary anchor housing 2302 can be dimensioned to fit the primary anchordriver 2304. In some embodiments, the primary anchor driver 2304 is atorque shaft. The primary anchor driver 2304 can designed to engage androtate the anchor 800 shown in FIG. 58J. The anchor 800 can beconsidered a primary anchor 800 to distinguish from one or moresecondary anchors.

The implant delivery system 2300 can include one or more release wires2306, 2308. In the illustrated embodiment, the implant delivery system2300 can include two release wires 2306, 2308, but other configurationsare contemplated (e.g., at least about, about, or no more than about,e.g., one release wire, two release wires, three release wires, fourrelease wires, five release wires, six release wires, etc.). The releasewires 2306, 2308 can extend proximally from the primary anchor housing2302 as shown in FIG. 58B. The release wires 2306, 2308 can extendthrough at least a portion of the primary anchor housing 2302. Therelease wires 2306, 2308 can be diametrically opposed within the primaryanchor housing 2302. The primary anchor housing 2302 can include slots2310, 2312 that allow the release wires 2306, 2308 to extend therethrough.

The release wires 2306, 2308 can extend back inside the primary anchorhousing 2302. The primary anchor housing 2302 can include slots 2314,2316 that allow the release wires 2306, 2308 to extend there through.The release wires 2306, 2308 can weave in and out of the primary anchorhousing 2302. The release wires 2306, 2308 can extend through the anchor800. The release wires 2306, 2308 can cross.

The release wires 2306, 2308 can extend along the coaptation assistanceelement 400, 500, 600, 700. The release wires 2306, 2308 can extendunderneath the coaptation assistance element 400, 500, 600, 700. Therelease wires 2306, 2308 can extend in opposite directions. The releasewires 2306, 2308 can be adjacent to the annulus. The release wires 2306,2308 can rigidly hold the primary anchor housing 2302 against theannular hub 420, 520, 620, 720 of the coaptation assistance element 400,500, 600, 700. The release wires 2306, 2308 can extend beyond thecoaptation assistance element 400, 500, 600, 700 as shown in FIG. 58A.

The implant delivery system 2300 can include one or more secondaryanchors 2320, 2322, 2324, 2326 shown in FIG. 58G (e.g., one secondaryanchor, two secondary anchors, three secondary anchors, four secondaryanchors (as shown), five secondary anchors, six secondary anchors, sevensecondary anchors, eight secondary anchors, etc.). In some embodiments,the secondary anchors 2320, 2322, 2324, 2326 can be helical anchors.Each secondary anchors 2320, 2322, 2324, 2326 can have a smallerdiameter than the primary anchor 800. The secondary anchors 2320, 2322,2324, 2326 can be configured to rotate to engage tissue in the annulus.

The implant delivery system 2300 can include one or more secondaryanchor drivers 2330, 2332, 2334, 2336, see FIG. 58D which illustratesthe secondary anchor driver 2330, (e.g., one secondary anchor driver,two secondary anchor drivers, three secondary anchor drivers, foursecondary anchor drivers, five secondary anchor drivers, six secondaryanchor drivers, seven secondary anchor drivers, eight secondary anchordrivers, etc.). In some embodiments, the secondary anchor driver 2330,2332, 2334, 2336 is a torque shaft. In some embodiments, the secondaryanchor driver 2330, 2332, 2334, 2336 is configured to rotate therespective secondary anchor 2320, 2322, 2324, 2326. In some embodiments,the secondary anchor driver 2330, 2332, 2334, 2336 is configured totranslate the respective secondary anchor 2320, 2322, 2324, 2326.

In some embodiments, the secondary anchor driver 2330, 2332, 2334, 2336can be coupled to the respective secondary anchor 2320, 2322, 2324, 2326according to any embodiment described herein.

The implant delivery system 2300 can include one or more secondaryanchor guide rails 2340, 2342, 2344, 2346, see FIG. 58C whichillustrates the secondary anchor guide rail 2340, (e.g., one secondaryanchor guide rail, two secondary anchor guide rails, three secondaryanchor guide rails, four secondary anchor guide rails, five secondaryanchor guide rails, six secondary anchor guide rails, seven secondaryanchor guide rails, eight secondary anchor guide rails, etc.). Thenumber of secondary anchor guide rails 2340, 2342, 2344, 2346 cancorrespond to the number of secondary anchors 2320, 2322, 2324, 2326.Each secondary anchor 2320, 2322, 2324, 2326 can include a passagewaythere through. The passageway can extend through the middle of thehelical wire of the secondary anchor 2320, 2322, 2324, 2326. Thesecondary anchor guide rail 2340, 2342, 2344, 2346 can be configured toextend through the respective passageway.

The implant delivery system 2300 can include one or more secondaryanchor tethers 2350, 2352, 2354, 2356 as shown in FIG. 58A (e.g., onesecondary anchor tether, two secondary anchor tethers, three secondaryanchor tethers, four secondary anchor tethers (as shown), five secondaryanchor tethers, six secondary anchor tethers, seven secondary anchortethers, eight secondary anchor tethers, etc.). The number of secondaryanchor tethers 2350, 2352, 2354, 2356 can correspond to the number ofsecondary anchors 2320, 2322, 2324, 2326. The secondary anchor tethers2350, 2352, 2354, 2356 can form a loop. Each secondary anchor tether2350, 2352, 2354, 2356 can include a first strand, a second strand, andan arc therebetween. Each secondary anchor tether 2350, 2352, 2354, 2356can loop around a respective release wire 2306, 2308 as describedherein. The secondary anchor tethers 2350, 2352, 2354, 2356 can extendthrough the coaptation assistance element 400, 500, 600, 700. Thecoaptation assistance element 400, 500, 600, 700 can include one or morepassageways to facilitate passage of the secondary anchor tether 2350,2352, 2354, 2356 there through. The release wires 2306, 2308 canmaintain the connection between the coaptation assistance element 400,500, 600, 700 and the secondary anchor tethers 2350, 2352, 2354, 2356.

The implant delivery system 2300 can include one or more radiopaquemarkers 2360, 2362, 2364, 2366 as shown in FIGS. 58A and 58B (e.g.,radiopaque marker, two radiopaque markers, three radiopaque markers,four radiopaque markers (as shown), five radiopaque markers, sixradiopaque markers, seven radiopaque markers, eight radiopaque markers,etc.). The number of radiopaque markers 2360, 2362, 2364, 2366 cancorrespond to the number of secondary anchor tethers 2350, 2352, 2354,2356. As described herein, the secondary anchor tethers 2350, 2352,2354, 2356 can form a loop around a respective release wire 2306, 2308as described herein. The radiopaque marker 2360, 2362, 2364, 2366 canencase the first strand and the second strand of the loop. Theradiopaque marker 2360, 2362, 2364, 2366 can encase the free end of thesecondary anchor tethers 2350, 2352, 2354, 2356. Each radiopaque marker2360, 2362, 2364, 2366 can be coupled to a corresponding secondaryanchor tether 2350, 2352, 2354, 2356. In some embodiments, theradiopaque marker 2360, 2362, 2364, 2366 can be crimped to therespective secondary anchor tether 2350, 2352, 2354, 2356. Theradiopaque marker 2360, 2362, 2364, 2366 can extend on one side of thecoaptation assistance element 400, 500, 600, 700. The radiopaque marker2360, 2362, 2364, 2366 can be on the opposite side of the coaptationassistance element 400, 500, 600, 700 as the release wires 2306, 2308.In the illustrated embodiment, the implant delivery system 2300 caninclude four radiopaque markers 2360, 2362, 2364, 2366 coupled to thefour secondary anchor tethers 2350, 2352, 2354, 2356, but fewerradiopaque markers may be employed. In some embodiments, each secondaryanchor tethers 2350, 2352, 2354, 2356 can include a radiopaque marker2360, 2362, 2364, 2366.

Each radiopaque marker 2360, 2362, 2364, 2366 can have a length, e.g.,between 0 and 5 mm, between 1 and 6 mm, between 2 and 7 mm, between 3and 8 mm, between 4 and 9 mm, between 5 and 10 mm, between 6 and 11 mm,between 7 and 12 mm, between 8 and 13 mm, between 9 and 14 mm, between10 and 15 mm, between 0 and 10 mm, between 5 and 15 mm, between 10 and20 mm, approximately 5 mm, approximately 10 mm, etc. Each radiopaquemarker 2360, 2362, 2364, 2366 can have a diameter or cross-section lessthan the dimeter of a lumen of the secondary anchor guide rails 2340,2342, 2344, 2346. In some embodiments, each secondary anchor guide rails2340, 2342, 2344, 2346 is configured to slide over the correspondingradiopaque marker 2360, 2362, 2364, 2366 to deliver the secondaryanchor. In some embodiments, each secondary anchor driver 2330, 2332,2334, 2336 is configured to slide over the corresponding radiopaquemarker 2360, 2362, 2364, 2366 to deliver the secondary anchor. In someembodiments, each secondary anchor 2320, 2322, 2324, 2326 is configuredto slide over the corresponding radiopaque marker 2360, 2362, 2364, 2366to be driven into tissue.

The radiopaque marker 2360, 2362, 2364, 2366 can serve many functions.In some embodiments, one advantageous purpose of the radiopaque marker2360, 2362, 2364, 2366 can be to prevent the secondary anchor tethers2350, 2352, 2354, 2356 from moving with respect to the surface of thecoaptation assistance element 400, 500, 600, 700. In some embodiments,preventing this movement thus eliminates the entanglement of thesecondary anchor tethers 2350, 2352, 2354, 2356 with the coaptationassistance element 400, 500, 600, 700, including the frame or struts asdescribed herein. The radiopaque marker 2360, 2362, 2364, 2366 canprovide a rigid connection between the secondary anchor tethers 2350,2352, 2354, 2356 and the coaptation assistance element 400, 500, 600,700. In some embodiments, the radiopaque marker 2360, 2362, 2364, 2366are fixed to the secondary anchor tethers 2350, 2352, 2354, 2356. Insome embodiments, the radiopaque marker 2360, 2362, 2364, 2366 are fixedto the coaptation assistance element 400, 500, 600, 700.

In some embodiments, an advantageous purpose of the radiopaque marker2360, 2362, 2364, 2366 can be to create a rigid segment to support thesecondary anchors 2320, 2322, 2324, 2326 as they are being engaged intothe surface of the coaptation assistance element 400, 500, 600, 700.This allows controlled engagement of the secondary anchors 2320, 2322,2324, 2326 with the coaptation assistance element 400, 500, 600, 700. Italso prevents entanglement of the secondary anchors 2320, 2322, 2324,2326 with the secondary anchor tethers 2350, 2352, 2354, 2356. Theradiopaque marker 2360, 2362, 2364, 2366 can reinforce the secondaryanchor tethers 2350, 2352, 2354, 2356, providing support and rigidity tothe secondary anchor tethers 2350, 2352, 2354, 2356. The radiopaquemarker 2360, 2362, 2364, 2366 can support the secondary anchor guiderails 2340, 2342, 2344, 2346 during orienting the trajectory of thesecondary anchor 2320, 2322, 2324, 2326.

In some embodiments, the purpose of the radiopaque markers 2360, 2362,2364, 2366 can be to provide a visual aid, under fluoroscopy, to verifythe engagement of the secondary anchors 2320, 2322, 2324, 2326 with thecoaptation assistance element 400, 500, 600, 700. The purpose of theradiopaque markers 2360, 2362, 2364, 2366 can be to evaluate the depthof the secondary anchors 2320, 2322, 2324, 2326 engagement based on thedistance between the hub of the secondary anchors 2320, 2322, 2324, 2326and the radiopaque marker s2360, 2362, 2364, 2366. The radiopaquemarkers 2360, 2362, 2364, 2366 can provide a visual indication of theplacement of the secondary anchor tethers 2350, 2352, 2354, 2356. Theradiopaque markers 2360, 2362, 2364, 2366 can provide a visualindication of the placement of the secondary anchor guide rails 2340,2342, 2344, 2346. The radiopaque markers 2360, 2362, 2364, 2366 canprovide a visual indication of the placement of the secondary anchors2320, 2322, 2324, 2326. The radiopaque markers 2360, 2362, 2364, 2366can determine the depth of insertion of the secondary anchors 2320,2322, 2324, 2326.

Referring to FIG. 58C, the secondary anchor guide rail 2340 isillustrated. While the secondary anchor guide rail 2340 is illustrated,each secondary anchor guide rail 2340, 2342, 2344, 2346 can includesimilar features. The flexible distal section of the secondary anchorguide rail 2340 can include a bend. The bend can be any angle from 30-90degrees, preferably 45 degrees. This passive bend allows steering of thesecondary anchor guide rail 2340. By rotating the proximal section ofthe secondary anchor guide rail 2340 in either direction, the distalbent section can be steered in different directions. This will allow theuser to orient the secondary anchor 2320 corresponding to the secondaryanchor guide rail 2340 in an optimal projection, before engaging thesecondary anchor 2320 into the coaptation assistance element 400, 500,600, 700 and the tissue.

Each secondary anchor guide rail 2340, 2342, 2344, 2346 can increase thesteerability of the corresponding secondary anchor 2320, 2322, 2324,2326. The secondary anchors 2320, 2322, 2324, 2326 can be orientedbefore engaging the secondary anchors 2320, 2322, 2324, 2326 in thetissue. Each secondary anchor guide rail 2340, 2342, 2344, 2346 canprovide two or more trajectories for the corresponding secondary anchor2320, 2322, 2324, 2326. Each secondary anchor guide rail 2340, 2342,2344, 2346 can be rotated which rotates the distal end with the bend.Each secondary anchor guide rail 2340, 2342, 2344, 2346 can be rotateduntil the distal end defines the preferred trajectory for thecorresponding secondary anchors 2320, 2322, 2324, 2326.

Referring to FIG. 58D, the secondary anchor guide rail 2340 isillustrated. The secondary anchor guide rail 2340 (only one shown here)is advance to contact the surface of the coaptation assistance element400, 500, 600, 700. The secondary anchor guide rail 2340 can be advancedalong the secondary anchor tethers 2350. The secondary anchor guide rail2340 can be locked, from the proximal end, to the secondary anchortethers 2350 once the secondary anchor guide rail 2340 reaches thecoaptation assistance element 400, 500, 600, 700. The secondary anchor2320 can be coupled to the secondary anchor drivers 2330 as describedherein.

Referring to FIG. 58E, the secondary anchor 2320 is advanced over thesecondary anchor guide rail 2340 toward the surface of the coaptationassistance element 400, 500, 600, 700. The secondary anchor 2320, usingthe secondary anchor drivers 2330, is advance to the distal tip of thesecondary anchor guide rail 2340.

Referring to FIG. 58F, the flexible distal section of the secondaryanchor guide rail 2340 includes a bend from 30-90 degrees, preferably 45degrees. This passive bend allows steering of the secondary anchor guiderail 2340. By rotating the proximal section of the secondary anchorguide rail 2340 in either direction, the distal bent section can besteered in different directions. This will allow the user to orient thesecondary anchor 2320 in an optimal projection, before engaging thesecondary anchor 2320 into the implant and the tissue

Referring to FIG. 58G, the secondary anchors 2320, 2322, 2324, 2326 areengaged in with the coaptation assistance element 400, 500, 600, 700.The secondary anchors 2320, 2322, 2324, 2326 are engaged with thetissue, such as the annulus. The secondary anchors 2320, 2322, 2324,2326 can be rotated and/or translated to engage the tissue. Thesecondary anchors 2320, 2322, 2324, 2326 can be inserted in the optimalorientation due to the flexible distal section of the secondary anchorguide rails 2340, 2342, 2344, 2346. In some embodiments, the optimalorientation of each of the secondary anchors 2320, 2322, 2324, 2326 canbe between 40 and 50 degrees with respect to the plane of mitral annulustoward the posterior annulus. Other angles are contemplated, e.g., 0degrees with respect to the plane of mitral annulus, 10 degrees withrespect to the plane of mitral annulus, 20 degrees with respect to theplane of mitral annulus, 30 degrees with respect to the plane of mitralannulus, 40 degrees with respect to the plane of mitral annulus, 50degrees with respect to the plane of mitral annulus, 60 degrees withrespect to the plane of mitral annulus, 70 degrees with respect to theplane of mitral annulus, 80 degrees with respect to the plane of mitralannulus, 90 degrees with respect to the plane of mitral annulus,approximately 45 degrees, between 15 and 45 degrees, between 30 and 60degrees, between 45 and 60 degrees, etc.

At this stage, all or any of the anchoring steps can be reversed. Forinstance, the secondary anchors 2320, 2322, 2324, 2326 can be disengagedwith the tissue. For instance, the coaptation assistance element 400,500, 600, 700 can be withdrawn into the delivery catheter. For instance,the coaptation assistance element 400, 500, 600, 700 can be retrievedthrough the transseptal sheath 1400.

Referring to FIGS. 58H and 581 , after the secondary anchors 2320, 2322,2324, 2326 are engaged with the coaptation assistance element 400, 500,600 and the tissue, the release wires 2306, 2308 can be released. Insome embodiments, the release wires 2306, 2308 are pulled back torelease the secondary anchor tethers 2350, 2352, 2354, 2356. Thesecondary anchor tethers 2350, 2352, 2354, 2356 can be retracted throughthe transseptal sheath 1400. The secondary anchor guide rails 2340,2342, 2344, 2346 can be retracted through the transseptal sheath 1400.The secondary anchor drivers 2330, 2332, 2334, 2336 can decouple fromthe secondary anchors 2320, 2322, 2324, 2326. The implant hub can berelease, as described herein. The secondary anchor drivers 2330, 2332,2334, 2336 can be retracted through the transseptal sheath 1400. Thesecondary anchor drivers 2330, 2332, 2334, 2336 can be pulled back anddecoupled from the corresponding secondary anchor. As shown, threeanchor drivers 2332, 2324, 2326 have been decoupled from theircorresponding anchors. The secondary anchor tethers 2350, the secondaryanchor guide rail 2340, and the secondary anchor driver 2330 can bewithdrawn together. The secondary anchor tether 2350, the secondaryanchor guide rail 2340, and the secondary anchor driver 2330 can bewithdrawn sequentially, separately, and/or independently.

Referring to FIG. 58J, after the secondary anchor drivers 2330, 2332,2334, 2336 are de-coupled and withdrawn into the transseptal sheath1440, the primary anchor housing 2302 can be retracted. The primaryanchor driver 2304 can be disposed and retained within the primaryanchor housing 2302. The primary anchor housing 2302 can be pulled backto detach from the coaptation assistance element 400, 500, 600. Theprimary anchor housing 2302 can be withdrawn into the transseptal sheath1440.

FIGS. 59A-59B illustrate the respective secondary anchor 2320 accordingto some embodiments. While the secondary anchor 2320 is illustrated,each secondary anchor 2320, 2322, 2324, 2326 can include similarfeatures.

The secondary anchor 2320 can include a shoulder 2372. The shoulder 2372can be configured to engage the secondary anchor driver 2330. Theshoulder 2372 can have features such as one or more windows 2374. Thewindows 2374 can be diametrically opposed, equally spaced, or otherwisespaced apart. While two windows 2374 are shown, other configurations ofwindows are contemplated (e.g., one window, two windows (shown), threewindows, four windows, five windows, six windows, etc.).

The secondary anchor 2320 can include a helical body 2386. The secondaryanchor 2320 can be formed or wound. The secondary anchor 2320 can bemade from an isodiametric wire. The wire can have a diameter of between0.006 inch and 0.025 inch, preferably, 0.017 inch. The anchoring segment2388 of the secondary anchor 2320 can be formed with a larger pitch ofbetween 0.5 and 1.5 mm, preferably 1 mm. The secondary anchor 2320 caninclude a secondary anchor locking segment 2390. The secondary anchorlocking segment 2390 can be a portion of the secondary anchor 2320between the shoulder 2372 and the anchoring segment 2388. The secondaryanchor locking segment 2390 of the secondary anchor 2320 can be formedat a pitch equal to the diameter of the wire. This will create no gapbetween the loops on the secondary anchor locking segment 2390. Once theanchoring segment 2388 of the secondary anchor 2320 is fully engaged inthe coaptation assistance element 400, 500, 600, 700 additional torquecould be applied to the secondary anchor 2320 to engage the secondaryanchor locking segment 2390 with the coaptation assistance element 400,500, 600, 700. The compression from the closed loops of the secondaryanchor locking segment 2390 can prevent the secondary anchor 2320 fromun-screwing from the secondary anchor locking segment 2390 during thecyclical motion of the tissue (e.g. heart beat). The smaller pitch ofthe locking segment 2390 can create a locking feature on the secondaryanchor 2320. The locking segment 2390 is intended to prevent un-screwingof the implant as the heart beats.

In FIG. 60 , the secondary anchor locking segment 2390 has been engagedin the lamination of the coaptation assistance element 400, 500, 600,700 to lock the secondary anchor 2320 to the top and bottom surfaces ofthe coaptation assistance element 400, 500, 600, 700. In FIG. 60 , theanchoring segment 2388 has been engaged into the tissue. In someembodiments, the coaptation assistance element 400, 500, 600, 700extends between the close pitch of adjacent helical spirals. The closepitch can be configured to securely couple to the coaptation assistanceelement 400, 500, 600, 700. Other configurations of locking segments arecontemplated.

In some embodiments, the secondary anchor 2320 can be formed using atapered wire. The smaller diameter of the tapered wire could be used toform the anchoring segment 2388 while the larger diameter of the wirecould be used to form the secondary anchor locking segment 2390. Thesecondary anchor locking segment 2390 can apply additional forces to thecoaptation assistance element 400, 500, 600, 700 thus preventing thesecondary anchor 2320 from un-screwing with cyclical motion when thesecondary anchor 2320 engaged in a tissue.

Referring to FIG. 61 , the heart is shown including the left atrium 10and the left ventricle 30. The mitral valve 60 is disposed between theleft atrium 10 and the left ventricle 30. The mitral valve 60 iscomposed of two leaflets, the anterior leaflet 12 and the posteriorleaflet 14. In a healthy heart, the two leaflets 12, 14 contact eachother during systole. The two leaflets 12, 14 open during diastole. Atthe beginning of diastole the aortic and pulmonary valves are closed toprevent back flow from the arteries into the ventricles. Shortlythereafter, these valves open to allow unimpeded flow from the atriainto the corresponding ventricles. Shortly after ventricular systolebegins, the tricuspid and mitral valves normally shut, forming a seal,which prevents flow from the ventricles back into the correspondingatria. The aortic valve 80 directs flow through the aorta and thence tothe periphery.

FIGS. 62A-62C illustrate an embodiment of a coaptation assistanceelement 1500. FIG. 62A illustrates a perspective view of the coaptationassistance element 1500. FIG. 62B illustrates a side view of thecoaptation assistance element 1500 in diastole. FIG. 62C illustrates aside view of the coaptation assistance element 1500 in systole. Thecoaptation assistance element 1500 can be similar to the coaptationassistance elements 400, 500, 600, or 700 and can include any featuredescribed herein, with certain elements described below. The coaptationassistance element 1500 can have a generally elongated shape. Thecoaptation assistance element 1500 can have a superior edge 1540,lateral edges 1570 and 1575, and an inferior edge 1580. In someembodiments, the superior edge 1540 has a length greater than of thelength of the inferior edge 1580, such that the transverse distancebetween lateral edges 1570 and 1575 generally decreases from superior toinferior on the coaptation assistance element 1500.

The coaptation assistance element 1500 can include a first surface 1505and a second surface 1515. The first surface 1505 or inferior surfacecan be disposed toward a mal-coapting native leaflet, in the instance ofa mitral valve, the posterior leaflet 14. The second surface 1515 orsuperior surface can be disposed toward the anterior leaflet 12. Thesuperior edge 1540 of the coaptation assistance element 1500 may becurved to match the general shape of the annulus or adjoining atrialwall. The superior edge 1540 can be curved upward, away from theposterior leaflet 14. In some embodiments, superior edge 1540 can becurved downward.

The coaptation assistance element 1500 can include an annular hub 1520.The annular hub 1520 can be relatively centrally located. The annularhub 1520 can be designed to engage the annular anchor 800. The annularanchor 800 may be engaged at a proximal end by a driver, describedherein. The annular hub 1520 may have a built-in or coupled annularanchor 800. The annular anchor 800 may comprise a helix rotatable withrespect to the annular hub 1520. The coaptation assistance element 1500can be delivered percutaneously as described herein by attachment of adelivery catheter to the annular hub 1520. The annular hub 1520 isdesigned to be placed adjacent to the annulus such that the annularanchor 800 can be driven into and anchored to the annulus.

The coaptation assistance element 1500 can include one or more struts1530. In some embodiments, one or more struts 1530 have one endterminating at the annular hub 1520 and the other end extending radiallyoutwardly toward the superior edge 1540, the lateral edges 1570 and1575, or the inferior edge 1580 of the coaptation assistance element1500. The struts 1530 may be composed of a radio-opaque material. Insome embodiments, the struts 1530 are composed of a resilientlydeformable material such as a shape memory metal, e.g., Nitinol or ashape memory polymer. In some embodiments, the struts 1530 may becomposed of other materials including cobalt-nickel, stainless steel,metals, alloys, polypropylene, high density polyethylene (PE), Dacron,acellular collagen matrix such as SIS, or other plastics, etc. Thestruts 1530 can be laser-cut from a Nitinol tube in some embodiments.The one or more struts 1530 can form the frame of the coaptationassistance element 1500. The struts 1530 can form a metal wire stentstructure.

The coaptation assistance element 1500 can include an annular section1510. The annular section 1510 can be positioned above the nativeleaflets when the coaptation assistance element 1500 is deployed. Theannular section 1510 can be positioned near the annulus when thecoaptation assistance element 1500 is deployed. The annular section 1510can be positioned to extend toward the atrial wall when the coaptationassistance element 1500 is deployed. The annular section 1510 caninclude a superior zone designed to be superior to another section ofthe coaptation assistance element 1500. The annular section 1510 can bea relatively flat, generally hemispherical section of the coaptationassistance element 1500. In some embodiments, the annular section 1510may be curved toward the annulus or atrial wall. One or more of thestruts 1530 may curve laterally from the hub 1520 toward the superioredge 1540 to assist in maintaining the shape of the annular section 1510of the coaptation assistance element 1500 upon deployment. The one ormore struts 1530 that support the annular section 1510 can be consideredatrial arms. The one or more struts 1530 can provide structuralstability to the coaptation assistance element 1500 in the annularsection 1510. The superior edge 1540 along the annular section 1510 cancurve upward or downward. The annular section 1510 can include the firstsurface 1505 toward the atrium and the second surface 1515 toward theannulus.

The coaptation assistance element 1500 can include a leaflet section1512. The leaflet section 1512 can be positioned over the posteriorleaflet 14 when the coaptation assistance element 1500 is deployed. Theleaflet section 1512 can extend downward from annulus when thecoaptation assistance element 1500 is deployed. The leaflet section 1512can extend between the anterior leaflet 12 and the posterior leaflet 14when the coaptation assistance element 1500 is deployed. The leafletsection 1512 can include an inferior zone designed to be positionedinferior to another section of the coaptation assistance element 1500.The leaflet section 1512 can be a generally triangular or taperedsection of the coaptation assistance element 1500. In some embodiments,the annular section 1510 may be curved or convex toward the anteriorleaflet 12. One or more of the struts 1530 may extend from the hub 1520toward the inferior edge 1580 to assist in maintaining the shape of theleaflet section 1512 of the coaptation assistance element 1500 upondeployment. One or more of the struts 1530 may extend from the hub 1520toward the lateral edges 1570, 1575 to assist in maintaining the shapeof the leaflet section 1512 of the coaptation assistance element 1500upon deployment. The one or more struts 1530 that support the leafletsection 1512 can be considered ventricular arms. The one or more struts1530 can provide structural stability to the coaptation assistanceelement 1500 in the leaflet section 1512. The leaflet section 1512 caninclude the first surface 1505 toward the posterior leaflet 14 and thesecond surface 1515 toward the anterior leaflet 12.

In some embodiments, the struts 1530 can be covered with one, two, ormore layers of coaptation assistance element body covering 1550. Thecoaptation assistance element body covering 1550 can include a layer ora plurality of layers (e.g., one layer, two layers, three layers, fourlayers, five layers, or more, or ranges incorporating any two of theforegoing values). In some embodiments, the first surface 1505 caninclude one or more layers. In some embodiments, the second surface 1515can include one or more layers. Any two or more layers of the pluralityof layers can include the same or different features, includingmaterial, length, width, thickness, etc. In some embodiments, one ormore layers extend along the entire, or only a portion of, the firstsurface 1505. In some embodiments, one or more layers extend along theentire, or only a portion of, the second surface 1515. In someembodiments, one or more layers extend along the entire, or only aportion of, the annular section 1510. In some embodiments, one or morelayers extend along the entire, or only a portion of, the leafletsection 1512. The layers can be formed from any process describedherein.

The coaptation assistance element body covering 1550 may be comprised ofa material or various materials as described herein. The coaptationassistance element body covering 1550 may be comprised of a materialsuch as a polymer, e.g., ePTFE. The coaptation assistance element bodycovering 1550 may be comprised of Dacron. Other materials for thecoaptation assistance element body covering 1550 include polyester,polyurethane foam, polycarbonate foam, biologic tissue such as porcinepericardium, processed bovine pericardium, pleura, peritoneum, silicone,Dacron, acellular collagen matrix, combinations thereof, etc. In someembodiments, the coaptation assistance element body covering 1550 caninclude a foam material surrounded by ePTFE. In some embodiments, thestruts 1530 can be formed with or embedded one or more layers ofcoaptation assistance element body covering 1550. In some embodiments,the struts 1530 can be encased or at least partially encased by thecoaptation assistance element body covering 1550.

In some embodiments, the annular section 1510, or a portion thereof, isreinforced. The annular section 1510 can be reinforced with one or moreadditional layers. In some embodiments, the leaflet section 1512, or aportion thereof, is reinforced. The leaflet section 1512 can bereinforced with one or more additional layers. The one or moreadditional layers can be located on the first surface 1505 or the secondsurface 1515. In some embodiments, the first surface 1505, or a portionthereof, is reinforced. In some embodiments, the second surface 1515, ora portion thereof, can be reinforced.

The coaptation assistance element 1500 can include a reduced profile indiastole and an expanded profile in systole as shown in FIGS. 62B-62C.The coaptation assistance element 1500 can be capable of expanding froma smaller profile to a larger profile to dimensions appropriate forplacement in between the valve's native leaflets 12, 14. The coaptationassistance element 1500 can comprise a leaflet-apposing valve bodyelement 1590. The leaflet-apposing valve body element 1590 can bedesigned to coapt with the native leaflet, for instance the anteriorleaflet 12 of the mitral valve 60.

The leaflet-apposing valve body element 1590 can be made of biologicaltissue. The leaflet-apposing valve body element 1590 can be made oftissue or valve material derived from animal species. Theleaflet-apposing valve body element 1590 can be made from tissue fromhuman donors. The tissue can originate from a porcine heart valve suchas the porcine aortic valve or a bovine cardiac tissue such as thepericardium sac surrounding the heart. The leaflet-apposing valve bodyelement 1590 can be made of biologic tissue such as bovine, swine,valve, pericardium, cardiac tissue, other tissue, or, combinationsthereof. The leaflet-apposing valve body element 1590 can be homograftor xenograft tissue. In some embodiments, the leaflet-apposing valvebody element 1590 comprises one or more layers of tissue.

These tissues can be treated and sterilized to prevent rejection fromthe patient. The leaflet-apposing valve body element 1590 can beconsidered a bioprosthetic valve or tissue valve. The leaflet-apposingvalve body element 1590 can include advantages such as improvedbiocompatibility, similar physiological hemodynamics compared with ahealthy valve, and reduced need for anticoagulation. Theleaflet-apposing valve body element 1590 made from tissue may reduce therisk of blood clotting on the surface of the leaflet-apposing valve bodyelement 1590. The leaflet-apposing valve body element 1590 can replicatethe form and function of the normal, healthy valve.

The leaflet-apposing valve body element 1590 can be coupled to anyportion of the coaptation assistance element 1500. The leaflet-apposingvalve body element 1590 can be coupled to one or more struts 1530. Theleaflet-apposing valve body element 1590 can be coupled to thecoaptation assistance element body covering 1550. The leaflet-apposingvalve body element 1590 can be coupled to the hub 1520. Theleaflet-apposing valve body element 1590 can extend from the annularsection 1510. The leaflet-apposing valve body element 1590 can extendparallel to the lateral edges 1570, 1575. The leaflet-apposing valvebody element 1590 can extend parallel to the inferior edge 1580. Theleaflet-apposing valve body element 1590 can extend over or cover atleast a portion of the leaflet section 1512. The leaflet-apposing valvebody element 1590 can be adjacent to at least a portion of the leafletsection 1512. The leaflet-apposing valve body element 1590 can extendover or cover at least a portion of the second surface 1515. Theleaflet-apposing valve body element 1590 can be adjacent to at least aportion of the second surface 1515.

The leaflet-apposing valve body element 1590 can be sewn onto to aportion of the coaptation assistance element 1500. The leaflet-apposingvalve body element 1590 can be sewn onto to the coaptation assistanceelement body covering 1550. The leaflet-apposing valve body element 1590can be sewn onto to the coaptation assistance element body covering 1550near the annular section 1510. The coaptation assistance element 1500may include a sewing skirt or sewing cuff. In some embodiments, thesewing skirt or cuff is coupled to the annular section 1510.

In some embodiments, the leaflet-apposing valve body element 1590 can beincorporated into the lamination or layer construction of the coaptationassistance element 1500. The leaflet-apposing valve body element 1590can be disposed between two layers of the coaptation assistance element1500. The leaflet-apposing valve body element 1590 can be extend beyondone or more layers of the coaptation assistance element 1500, forinstance a lamination layer of the second surface 1515 of the annularsection 1510. The leaflet-apposing valve body element 1590 can be extendover or cover at least a portion of one or more layers of the coaptationassistance element 1500, for instance a lamination layer of the secondsurface 1515 of the leaflet section 1512.

The leaflet-apposing valve body element 1590 can be made of syntheticmaterials. The leaflet-apposing valve body element 1590 can be madePTFE, Dacron, ePTFE, polyester, polyurethane foam, or polycarbonatefoam. The leaflet-apposing valve body element 1590 can be made abiocompatible polymer. The leaflet-apposing valve body element 1590 canbe made of one or more materials.

In some embodiments, the leaflet-apposing valve body element 1590 caninclude one or more struts 1530 or other support members. In someembodiments, the one or more struts 1530 can extend from the hub 1520 atalong at least a portion of the leaflet-apposing valve body element1590. The leaflet-apposing valve body element 1590 can include any frameor support structure. The leaflet-apposing valve body element 1590 caninclude a mesh or other cross-linked support structure. In someembodiments, the leaflet-apposing valve body element 1590 can includethe coaptation assistance element body covering 1550. In someembodiments, the coaptation assistance element body covering 1550 canextend from the hub 1520 at along at least a portion of theleaflet-apposing valve body element 1590. In some embodiments, theleaflet-apposing valve body element 1590 can include a combination ofmaterials including one or more natural or synthetic tissue materials.In some embodiments, the leaflet-apposing valve body element 1590 caninclude a combination of materials including one or more tissuematerials and one or more polymers.

The leaflet-apposing valve body element 1590 can include a coaptationsurface 1560. The coaptation surface 1560 can define a relativelyinferior zone of the leaflet-apposing valve body element 1590. Asdescribed herein, the coaptation surface 1560 can contact the anteriorleaflet 12. The leaflet section 1512 and the leaflet-apposing valve bodyelement 1590 can cover or lie over a portion of the posterior leaflet14. The leaflet section 1512 and the leaflet-apposing valve body element1590 can be positioned so that the anterior leaflet 12 coapts with thecoaptation surface 1560 during systole. The leaflet-apposing valve bodyelement 1590 and anterior leaflet 12 can maintain the valve seal at theannular ring.

The leaflet-apposing valve body element 1590 can be reinforced near thecoaptation surface 1560. The anterior portion of the coaptation surface1560 can be reinforced. The posterior portion of the coaptation surface1560 can be reinforced. The one or more additional layers can extendover the coapatation surface 1560. The one or more additional layers canextend over a portion of the coaptation surface 1560 larger than thecontact area with the anterior leaflet 12. The coaptation surface 1560can be reinforced with any material described herein. The coaptationsurface 1560 can be reinforced with ePTFE.

The leaflet-apposing valve body element 1590 can be designed to increasethe distance between the leaflet-apposing valve body element 1590 andthe leaflet surface 1512 in an expanded state. The leaflet-apposingvalve body element 1590 can be designed to increase the distance betweenthe leaflet-apposing valve body element 1590 and the second surface 1515in an expanded state. The leaflet-apposing valve body element 1590 canbe designed to increase the distance between the leaflet-apposing valvebody element 1590 and the inferior edge 1580 in an expanded state. Theleaflet-apposing valve body element 1590 can form a triangular shapewith the leaflet surface 1512 in the expanded state.

The leaflet-apposing valve body element 1590 can include chords 1592 tostabilize the leaflet-apposing valve body element 1590. The chords 1592can prevent or limit the leaflet-apposing valve body element 1590 fromprolapsing. The chords 1592 can extend between inferior edges of theleaflet-apposing valve body element 1590 and the leaflet section 1512.The chords 1592 can extend between one or more lateral edges of theleaflet-apposing valve body element 1590 and the leaflet section 1512.The leaflet-apposing valve body element 1590 can include one or morechords (e.g., one, two, three, or four, etc.).

The leaflet-apposing valve body element 1590 can form a gap between theleaflet-apposing valve body element 1590 and the second surface 1515.The leaflet-apposing valve body element 1590 can have at least one fixedend and at least one free end. The leaflet-apposing valve body element1590 can be fixed or coupled near the annular hub 1520. Theleaflet-apposing valve body element 1590 can be free for at leastlimited movement relative to the second surface 1515 near the inferioredge 1580.

The leaflet-apposing valve body element 1590 can fill the gap betweenthe incompetent (mal-coapting) leaflets in the expanded state. In someembodiments, the leaflet-apposing valve body element 1590 is configuredto expand in systole. In some embodiments, the leaflet-apposing valvebody element 1590 is configured to contract in diastole. In someembodiments, the leaflet-apposing valve body element 1590 is configuredto mimic the cardiac cycle by movement of the leaflet-apposing valvebody element 1590.

In some embodiments, the leaflet-apposing valve body element 1590 can bedesigned to expand outward based on motion of the posterior leaflet 14during systole. In some embodiments, the leaflet-apposing valve bodyelement 1590 can be designed to expand outward based on motion of theanterior leaflet 12 during systole. In some embodiments, theleaflet-apposing valve body element 1590 can be designed to expandoutward based on motion of the annulus or other tissue during systole.In some embodiments, the leaflet-apposing valve body element 1590 isdesigned to be actuated. The leaflet-apposing valve body element 1590can be actuated to expand in systole. In some embodiments, theleaflet-apposing valve body element 1590 is expanded by a force duringsystole. In some embodiments, the leaflet-apposing valve body element1590 is expanded by a blood flow during systole. In some embodiments,the leaflet-apposing valve body element 1590 is expanded based onpressure build-up within the heart. In some embodiments, theleaflet-apposing valve body element 1590 is expanded based on thecardiac cycle.

In some embodiments, the leaflet-apposing valve body element 1590 can bedesigned to contract inward based on motion of the posterior leaflet 14during diastole. In some embodiments, the leaflet-apposing valve bodyelement 1590 can be designed to contract inward based on motion of theanterior leaflet 12 during diastole. In some embodiments, theleaflet-apposing valve body element 1590 can be designed to contractinward based on motion of the annulus or other tissue during diastole.In some embodiments, the leaflet-apposing valve body element 1590 isdesigned to be actuated. The leaflet-apposing valve body element 1590can be actuated to contract in diastole. In some embodiments, theleaflet-apposing valve body element 1590 is contracted by a force duringdiastole. In some embodiments, the leaflet-apposing valve body element1590 is contracted by a blood flow during diastole. In some embodiments,the leaflet-apposing valve body element 1590 is contracted based onpressure build-up within the heart. In some embodiments, theleaflet-apposing valve body element 1590 is contracted based on thecardiac cycle.

In some embodiments, the leaflet-apposing valve body element 1590 ismoved away the second surface 1515 of the coaptation assistance element1500 during systole and moved toward the second surface 1515 duringdiastole. The leaflet-apposing valve body element 1590 can be spacedapart from the inferior edge 1580 during systole and be adjacent to theinferior edge 1580 during diastole. The leaflet-apposing valve bodyelement 1590 can be biased outward from the inferior end 1580 duringsystole or be biased inward from the inferior edge 1580 during diastole.In some methods, the leaflet-apposing valve body element 1590 isretained by the chords 1592 during systole. The leaflet-apposing valvebody element 1590 can move outward a pre-determined distance based onthe length of the one or more chords 1592. In some embodiments, thechords 1592 stabilize the leaflet-apposing valve body element 1590during motion.

In some embodiments, the leaflet-apposing valve body element 1590 caninclude a neutral configuration. The neutral configuration can be theexpanded configuration during systole or the contracted configurationduring diastole. The spring force of the leaflet-apposing valve bodyelement 1590 can be determined based on the force applied by theposterior leaflet 14 to expand or contract the leaflet-apposing valvebody element 1590. In some methods, the posterior leaflet 14 overcomesthis biasing force to compress or reduce the spacing between theleaflet-apposing valve body element 1590 and the inferior edge 1580.

In some embodiments, the leaflet-apposing valve body element 1590 can bedesigned to mimic and function like a healthy heart. In someembodiments, the leaflet-apposing valve body element 1590 can expand andcontract with each heartbeat, permitting proper blood flow through thevalve. In some embodiments, the leaflet-apposing valve body element 1590can function as a tissue or biological valve. In some embodiments, theleaflet-apposing valve body element 1590 can be a transplant from onespecies to another. In some embodiments, the leaflet-apposing valve bodyelement 1590 can be a xenograft. In some embodiments, theleaflet-apposing valve body element 1590 can be a biological tissuecoupled to the frame of the coaptation assistance element 1500. Thetissue can be harvest from cows, horses, swine, or any other species. Insome embodiments, the leaflet-apposing valve body element 1590 can beformed of the pericardial sac. In some embodiments, the leaflet-apposingvalve body element 1590 can be formed of any extremely durable tissue.In some embodiments, the leaflet-apposing valve body element 1590 can beflexible.

FIG. 63 illustrates an embodiment of the coaptation assistance element1500 deployed within the heart mitral valve. The coaptation zone betweenthe leaflets is not a simple line, but rather a curved funnel-shapedsurface interface. In some embodiments, the coaptation assistanceelement 1500 is placed over the posterior leaflet 14 to create a newsurface onto which the native leaflet, here the anterior leaflet 12, cancoapt. The mitral valve 60 is shown with the anterior leaflet 12 and theposterior leaflet 14. The zone of coaptation occurs between the anteriorleaflet 12 and the coaptation surface 1560 of the leaflet-apposing valvebody element 1590.

The coaptation assistance element 1500 can be anchored to the annuluswith the primary anchor 800 as described herein. The coaptationassistance element 1500 can cover the posterior leaflet 14. In systole,the leaflet-apposing valve body element 1590 is in an expanded position.In systole, the leaflet-apposing valve body element 1590 can provide thecoaptation surface 1560 for the anterior leaflet 12 to seal against.

A properly functioning mitral valve 60 of a heart is open duringdiastole to allow blood to flow along a flow path from the left atrium10 toward the left ventricle 30 and thereby fill the left ventricle. Thefunctioning anterior leaflet 12 and the leaflet-apposing valve bodyelement 1590 closes and effectively seals the left ventricle 30 from theleft atrium 10 during systole, first passively then actively by increasein ventricular pressure, thereby allowing contraction of the hearttissue surrounding the left ventricle to advance blood throughout thevasculature.

FIG. 64A-64D illustrate an embodiment of a coaptation assistance element1600. FIG. 64A-64B illustrates perspective views of the coaptationassistance element 1600. FIG. 64C-64D illustrates side views of thecoaptation assistance element 1600. The coaptation assistance element1600 can be similar to the coaptation assistance elements 400, 500, 600,700, or 1500 and can include any feature described herein, with certainelements described below. The coaptation assistance element 1600 canhave a generally elongated shape. The coaptation assistance element 1600can have a superior edge 1640, lateral edges 1670 and 1675, and aninferior edge 1680. In some embodiments, the superior edge 1640 has alength greater than that of inferior edge 1680, such that the transversedistance between lateral edges 1670 and 1675 generally decreases fromsuperior to inferior. The coaptation assistance element 1600 can includea first surface 1605 and a second surface 1615. The first surface 1605or inferior surface can be disposed toward a mal-coapting nativeleaflet, in the instance of a mitral valve, the posterior leaflet 14 orthe annulus. The second surface 1615 or superior surface can be disposedtoward the anterior leaflet 12 or the atrium.

The coaptation assistance element 1600 can include an annular hub 1620.The annular hub 1620 can be designed to engage the annular anchor 800.The annular hub 1620 is designed to be placed adjacent to the annulussuch that the annular anchor 800 can be driven into and anchored to theannulus.

The coaptation assistance element 1600 can include one or more struts1630. In some embodiments, one or more struts 1630 have one endterminating at the annular hub 1620 and the other end extending radiallyoutwardly toward the superior edge 1640, the lateral edges 1670 and1675, or the inferior edge 1680 of the coaptation assistance element1600. In some embodiments, the struts 1630 are composed of a resilientlydeformable material such as a shape memory metal, Nitinol, a shapememory polymer, cobalt-nickel, stainless steel, metals, alloys,polypropylene, high density polyethylene (PE), Dacron, acellularcollagen matrix such as SIS, or other plastics, etc. The one or morestruts 1630 can form the frame of the coaptation assistance element1600.

The coaptation assistance element 1600 can include an annular section1610. The annular section 1610 can be positioned near the annulus whenthe coaptation assistance element 1600 is deployed. The annular section1610 can be a relatively flat, generally hemispherical section of thecoaptation assistance element 1600. The annular section 1610 can includethe first surface 1605 toward the atrium and the second surface 1615toward the annulus.

The coaptation assistance element 1600 can include a leaflet section1612. The leaflet section 1612 can be positioned over the posteriorleaflet 14 when the coaptation assistance element 1600 is deployed. Theleaflet section 1612 can extend downward from annulus when thecoaptation assistance element 1600 is deployed. The leaflet section 1612can be a curved, generally triangular or tapered section of thecoaptation assistance element 1600. The leaflet section 1612 can includethe first surface 1605 toward the posterior leaflet 14 and the secondsurface 1615 toward the anterior leaflet 12.

In some embodiments, the struts 1630 can be covered with one, two, ormore layers of coaptation assistance element body covering 1650. Thecoaptation assistance element body covering 1650 can include a layer ora plurality of layers (e.g., one layer, two layers, three layers, fourlayers, five layers, or more, or ranges incorporating any two of theforegoing values). In some embodiments, the first surface 1605, or aportion thereof, can include one or more layers. In some embodiments,the second surface 1615, or a portion thereof, can include one or morelayers. Any two or more layers of the plurality of layers can includethe same or different features, including material, length, width,thickness, etc. The coaptation assistance element body covering 1650 maybe comprised of a material or various layers as described herein. Insome embodiments, the annular section 1610, or a portion thereof, isreinforced. In some embodiments, the leaflet section 1612, or a portionthereof, is reinforced. The one or more additional layers can be locatedon the first surface 1605 or the second surface 1615.

The coaptation assistance element 1600 can include a reduced profile indiastole as shown in FIGS. 64A and 64C and an expanded profile insystole as shown in FIGS. 64B and 64D. The coaptation assistance element1600 can be capable of expanding from a smaller profile to a largerprofile to dimensions appropriate for placement in between the valve'snative leaflets. The coaptation assistance element 1600 can comprise aleaflet-apposing valve body element 1694. The leaflet-apposing valvebody element 1694 can include the coaptation surface 1660. Theleaflet-apposing valve body element 1694 can be designed to coapt withthe native leaflet, for instance the anterior leaflet 12 of the mitralvalve 60.

The leaflet-apposing valve body element 1694 can be made of one or moreexpandable materials. The leaflet-apposing valve body element 1694 canbe made of medical grade polyurethane foam. The leaflet-apposing valvebody element 1694 can be covered with a material such as ePTFE. Theleaflet-apposing valve body element 1694 may be comprised of a materialsuch as a polymer. Other materials for the leaflet-apposing valve bodyelement 1694 include polyester, polyurethane foam, polycarbonate foam,silicone, Dacron, acellular collagen matrix, combinations thereof, etc.In some embodiments, the leaflet-apposing valve body element 1694 caninclude a foam material surrounded by ePTFE. In some embodiments, theleaflet-apposing valve body element 1694 comprises one or more layers ofexpandable material.

In some embodiments, the leaflet-apposing valve body element 1694 canhave an insertion volume within the deployment catheter and a deployedvolume greater than the insertion volume. In some embodiments, theleaflet-apposing valve body element 1694 is expandable within the heartso as to increase a thickness of the leaflet-apposing valve body element1694. In some embodiments, the leaflet-apposing valve body element 1694is volumetrically expandable. In some embodiments, the leaflet-apposingvalve body element 1694 is expandable in thickness. In some embodiments,the leaflet-apposing valve body element 1694 is expandable to increasethe distance from the first surface 1605. In some embodiments, theleaflet-apposing valve body element 1694 is expandable to increase thedistance from the second surface 1615.

In some embodiments, the leaflet-apposing valve body element 1694comprises a permeable material. In some embodiments, theleaflet-apposing valve body element 1694 expands by increasing theretention of fluid within the permeable material. In some embodiments,the coaptation assist body 1600 is configured to volumetrically expandwhen released in the heart. In some embodiments, the leaflet-apposingvalve body element 1694 is inflated using inflation fluid introducedfrom outside a vascular system of the patient. In some embodiments, theleaflet-apposing valve body element 1694 is inflated with hydrogel. Insome embodiments, the leaflet-apposing valve body element 1694 withcollagen. In some embodiments, the leaflet-apposing valve body element1694 with a polymer. In some embodiments, the leaflet-apposing valvebody element 1694 is configured to volumetrically expand with fluid ofthe heart. In some embodiments, the leaflet-apposing valve body element1694 is inflated with blood.

The leaflet-apposing valve body element 1694 can be coupled to anyportion of the coaptation assistance element 1600. The leaflet-apposingvalve body element 1694 can be coupled to one or more struts 1630. Theleaflet-apposing valve body element 1694 can be coupled to thecoaptation assistance element body covering 1650. The leaflet-apposingvalve body element 1694 can extend over or cover at least a portion ofthe leaflet section 1612. The leaflet-apposing valve body element 1694can be adjacent to at least a portion of the leaflet section 1612. Theleaflet-apposing valve body element 1694 can extend over or cover atleast a portion of the second surface 1615. The leaflet-apposing valvebody element 1694 can be adjacent to at least a portion of the secondsurface 1515. The leaflet-apposing valve body element 1694 can extendparallel to the lateral edges 1670, 1675. The leaflet-apposing valvebody element 1694 can extend parallel to the inferior edge 1680.

The leaflet-apposing valve body element 1694 can be coupled to theleaflet section 1612 with adhesive. The leaflet-apposing valve bodyelement 1694 can be sewn onto to coaptation assistance element bodycovering 1650. In some embodiments, the leaflet-apposing valve bodyelement 1694 can be incorporated into the lamination or layerconstruction of the coaptation assistance element 1600. Theleaflet-apposing valve body element 1694 can be disposed between twolayers of the coaptation assistance element 1600. The leaflet-apposingvalve body element 1694 can be extend beyond one or more layers of thecoaptation assistance element 1600, for instance a lamination layer ofthe second surface 1615 of the annular section 1610. Theleaflet-apposing valve body element 1694 can be extend over or cover oneor more layers of the coaptation assistance element 1600, for instance alamination layer of the second surface 1615 of the leaflet section 1612.

In some embodiments, the leaflet-apposing valve body element 1694, or aportion thereof, can include one or more struts 1630 or other supportmembers. The leaflet-apposing valve body element 1694 can include anyframe or support structure. In some embodiments, the leaflet-apposingvalve body element 1694, or a portion thereof, can include thecoaptation assistance element body covering 1550.

The leaflet-apposing valve body element 1694 can include the coaptationsurface 1660. The coaptation surface 1660 can contact the anteriorleaflet 12. The leaflet section 1612 and the leaflet-apposing valve bodyelement 1694 can cover or lie over a portion of the posterior leaflet14. The leaflet section 1612 and the leaflet-apposing valve body element1690 can be positioned so that the anterior leaflet 12 coapts with thecoaptation surface 1660 during systole. The leaflet-apposing valve bodyelement 1694 and anterior leaflet 12 can maintain the valve seal at theannular ring. The leaflet-apposing valve body element 1694 can bereinforced near the coaptation surface 1660. The anterior portion of thecoaptation surface 1660 can be reinforced. The posterior portion of thecoaptation surface 1660 can be reinforced. The one or more additionallayers can extend over the coaptation surface 1660.

The leaflet-apposing valve body element 1694 can be designed to increasethe thickness of the leaflet-apposing valve body element 1694. Theleaflet-apposing valve body element 1694 can be designed to increase thedistance between the coaptation surface 1660 and the first surface 1605in the inflated state. In some embodiments, the leaflet-apposing valvebody element 1694 can form a triangular shape in the inflated state. Insome embodiments, the leaflet-apposing valve body element 1694 can matchthe perimeter or shape of the leaflet section 1612 in the inflatedstate. In some embodiments, the leaflet-apposing valve body element 1694can match the perimeter or shape of the leaflet section 1612 in thedeflated state.

The leaflet-apposing valve body element 1694 can be adjacent to theleaflet section 1612 in the inflated and deflated state. Theleaflet-apposing valve body element 1694 can be affixed or rigidlycoupled to the leaflet section 1612 in the inflated and deflated state.The leaflet-apposing valve body element 1694 can have at least two fixedends. The leaflet-apposing valve body element 1694 can be fixed orcoupled near the annular section 1610. The leaflet-apposing valve bodyelement 1590 can be fixed or coupled near the inferior edge 1680. Theleaflet-apposing valve body element 1590 can be fixed or coupled nearthe lateral edges 1670, 1675.

The leaflet-apposing valve body element 1694 can fill the gap betweenthe incompetent (mal-coapting) leaflets in the inflated state. In someembodiments, the leaflet-apposing valve body element 1694 is configuredto inflate in systole. In some embodiments, the leaflet-apposing valvebody element 1694 is configured to deflate in diastole. In someembodiments, the leaflet-apposing valve body element 1694 is configuredto mimic the cardiac cycle by movement of the leaflet-apposing valvebody element 1694.

In some embodiments, the leaflet-apposing valve body element 1694 isdesigned to inflate upon motion of the posterior leaflet during diastoleand deflate upon motion of the posterior leaflet during systole. In someembodiments, the leaflet-apposing valve body element 1694 is designed toinflate upon motion of the annulus or other tissue during diastole anddeflate upon motion of the annulus or other tissue during systole. Insome embodiments, the leaflet-apposing valve body element 1694 isdesigned to inflate upon a force during diastole and deflate upon aforce during systole. In some embodiments, the leaflet-apposing valvebody element 1694 is designed to inflate upon fluid flow during diastoleand deflate upon fluid flow during systole. In some embodiments, theleaflet-apposing valve body element 1694 is designed to inflate uponpressure building-up during diastole and deflate upon pressure releaseduring systole. In some embodiments, the leaflet-apposing valve bodyelement 1590 is inflated or deflated based on the cardiac cycle.

In some embodiments, the leaflet-apposing valve body element 1694 isdesigned to be actuated. The leaflet-apposing valve body element 1694can be actuated to inflate in systole. The leaflet-apposing valve bodyelement 1694 can be actuated to deflate in diastole. Theleaflet-apposing valve body element 1694 can be actuated to inflate witha fluid, such as a hydrogel, collagen, or other polymer. Theleaflet-apposing valve body element 1694 can be actuated to remove thefluid.

In some embodiments, the leaflet-apposing valve body element 1694comprises a balloon. In some embodiments, the leaflet-apposing valvebody element 1694 is designed to be actuated. The leaflet-apposing valvebody element 1694 can be actuated to inflate the balloon in systole andactuated to deflate the balloon in diastole. The balloon of theleaflet-apposing valve body element 1694 can be inflated with a solid,liquid, or gas. The balloon of the leaflet-apposing valve body element1694 can be deflated by removal of the solid, liquid, or gas.

In some embodiments, the leaflet-apposing valve body element 1694 can bedesigned to mimic and function like a healthy heart. In someembodiments, the leaflet-apposing valve body element 1694 can beinflated and deflated with each heartbeat, permitting proper blood flowthrough the valve.

FIG. 65 illustrates an embodiment of the coaptation assistance element1600 deployed within the heart mitral valve. In some embodiments, thecoaptation assistance element 1600 is placed over the posterior leaflet14 to create a new surface onto which the native leaflet, here theanterior leaflet 12, can coapt. The zone of coaptation occurs betweenthe anterior leaflet 12 and the coaptation surface 1660 of theleaflet-apposing valve body element 1694.

The coaptation assistance element 1600 can be anchored to the annuluswith the primary anchor 800. In systole, the leaflet-apposing valve bodyelement 1694 is in an inflated position. In systole, theleaflet-apposing valve body element 1694 can provide the coaptationsurface 1560 for the anterior leaflet 12 to seal against. In diastole,the leaflet-apposing valve body element 1694 is in a deflated position.

FIG. 66A-66D illustrate an embodiment of a coaptation assistance element1700. FIG. 66A-66B illustrates perspective views of the coaptationassistance element 1700. FIG. 66C-66D illustrates side views of thecoaptation assistance element 1700. The coaptation assistance element1700 can be similar to the coaptation assistance elements 400, 500, 600,700, 1500, or 1600 and can include any feature described herein, withcertain elements described below.

FIG. 66A illustrates the coaptation assistance element 1700 with anexpandable segment deflated. FIG. 66B illustrates the coaptationassistance element 1700 with the expandable segment inflated. FIG. 66Cillustrates the coaptation assistance element 1700 with the expandablesegment collapsed during implantation for a smaller delivery profile.FIG. 66D illustrates the coaptation assistance element 1700 with theexpandable segment filled or expanded after implantation. In someembodiments, the coaptation assistance element 1700 can be permanentlyexpanded as described herein.

The coaptation assistance element 1700 can have a superior edge 1740,lateral edges 1770 and 1775, and an inferior edge 1780. The coaptationassistance element 1700 can include a first surface 1705 and a secondsurface 1715. The coaptation assistance element 1700 can include anannular hub 1720 designed to engage the annular anchor 800. The annularhub 1720 is designed to be placed adjacent to the annulus such that theannular anchor 800 can be driven into and anchored to the annulus. Thecoaptation assistance element 1700 can include one or more struts 1730.In some embodiments, one or more struts 1730 have one end terminating atthe annular hub 1720 and the other end extending radially outwardlytoward the superior edge 1740, the lateral edges 1770 and 1775, or theinferior edge 1780 of the coaptation assistance element 1700. In someembodiments, the struts 1730 can be covered with one, two, or morelayers of coaptation assistance element body covering 1750. Thecoaptation assistance element body covering 1750 may be comprised of amaterial or various layers as described herein.

The coaptation assistance element 1700 can include an annular section1710 designed to be positioned near the annulus when the coaptationassistance element 1700 is deployed. The coaptation assistance element1700 can include a leaflet section 1712 designed to be positioned overthe posterior leaflet 14 when the coaptation assistance element 1700 isdeployed. The leaflet section 1712 can extend downward from annulus whenthe coaptation assistance element 1700 is deployed.

The coaptation assistance element 1700 can include an expanded profileas shown in FIG. 67A. In some methods, the coaptation assistance element1700 is fixed to the posterior aspect of the mitral valve. After thecoaptation assistance element 1700 is fixed to the posterior aspect ofthe mitral valve, the coaptation assistance element 1700 is expandedpermanently. The expansion of the coaptation assistance element 1700 maybe performed on real-time echocardiographic evaluation of the MRreduction. The operator may continue expanding the expandable coaptationsegment until optimal MR reduction is achieved. Then the volume and theshape of the coaptation assistance element 1700 can be locked in thatposition permanently. Other imaging techniques can be utilized tovisualize the coaptation assistance element 1700 and/or monitor theexpansion of the coaptation assistance element 1700.

In some embodiments, the coaptation assistance element 1700 isselectively inflated. In some embodiments, the coaptation assistanceelement 1700 is inflated to a discrete size or shape. In someembodiments, the coaptation assistance element 1700 is inflated to adiscrete volume. In some embodiments, the coaptation assistance element1700 is expanded to a single expanded configuration. In someembodiments, the coaptation assistance element 1700 is expanded to oneof a plurality of expanded configurations. In some embodiments, thecoaptation assistance element 1700 is expanded to dimensions appropriatefor placement in between the valve's native leaflets.

In some embodiments, the coaptation assistance element 1700 can beexpanded within the body of the patient. In some embodiments, thecoaptation assistance element 1700 can be expanded within the heart ofthe patient. In some embodiments, the coaptation assistance element 1700can be expanded near the annulus. In some embodiments, the coaptationassistance element 1700 can be expanded after being positioned betweenthe leaflets. In some embodiments, the coaptation assistance element1700 can be expanded after being secured to the annulus with the anchor800.

In some embodiments, The coaptation assistance element 1700 can includea reduced profile for insertion into the mitral valve as shown in FIG.67B. In some embodiments, the coaptation assistance element 1700 canhave a reduced profile after being positioned between the leaflets. Insome embodiments, the coaptation assistance element 1700 can have areduced profile when anchored to the annulus. The coaptation assistanceelement 1700 can be expanded before or after being positioned betweenthe leaflets. The coaptation assistance element 1700 can be expandedbefore or after being anchored to the annulus. The expandable coaptationsegment can be collapsed during delivery to allow for a smaller profile.FIG. 67B illustrates the mitral valve during implantation.

The coaptation assistance element 1700 can be capable of expanding froma smaller profile to a larger, expanded profile. In some embodiments,the coaptation assistance element 1700 can comprise a leaflet-apposingvalve body element 1794. The leaflet-apposing valve body element 1794can include the coaptation surface 1760. The leaflet-apposing valve bodyelement 1794 can be designed to coapt with the native leaflet, forinstance the anterior leaflet 12 of the mitral valve 60. Theleaflet-apposing valve body element 1794 can be expandable. In someembodiments, the leaflet-apposing valve body element 1794 is the onlyportion of the coaptation assistance element 1700 that expands. In someembodiments, other portions of the coaptation assistance element 1700expand. In some embodiments, only a portion of the coaptation assistanceelement 1700 facing the anterior leaflet expands. In some embodiments, aportion of the coaptation assistance element 1700 does not expand. Insome embodiments, an entire surface of the coaptation assistance element1700 expands. In some embodiments, the second surface 1715 of thecoaptation assistance element 1700 expands.

In some embodiments, the leaflet-apposing valve body element 1794 cancomprise one or more expandable materials. The leaflet-apposing valvebody element 1794 can comprise medical grade polyurethane foam. Theleaflet-apposing valve body element 1794 can be covered with a materialsuch as ePTFE. The leaflet-apposing valve body element 1794 can comprisea polymer. Other materials for the leaflet-apposing valve body element1794 include polyester, polyurethane foam, polycarbonate foam, silicone,Dacron, acellular collagen matrix, combinations thereof, etc. In someembodiments, the leaflet-apposing valve body element 1794 can include afoam material surrounded by ePTFE. In some embodiments, theleaflet-apposing valve body element 1794 comprises one or more layers ofexpandable material. In some embodiments, the leaflet-apposing valvebody element 1794 comprises a permeable material.

In some embodiments, the leaflet-apposing valve body element 1794 can bea balloon. In some embodiments, the leaflet-apposing valve body element1794 can be foam. In some embodiments, the leaflet-apposing valve bodyelement 1794 can be inflated with hydrogel or collagen or otherpolymers. In some embodiments, the leaflet-apposing valve body element1794 is designed to be actuated in order to expand. In some embodiments,the leaflet-apposing valve body element 1794 expandable in volume and/orthickness.

The leaflet-apposing valve body element 1794 can be coupled to anyportion of the coaptation assistance element 1700. The leaflet-apposingvalve body element 1794 can include the coaptation surface 1760. Thecoaptation surface 1760 can contact the anterior leaflet 12. Theleaflet-apposing valve body element 1794 can be inflated and positionedso that the anterior leaflet 12 coapts with the coaptation surface 1760during systole. In some embodiments, the leaflet-apposing valve bodyelement 1794 is configured to be expanded in systole. In someembodiments, the leaflet-apposing valve body element 1794 is configuredto be expanded in diastole. In some embodiments, the leaflet-apposingvalve body element 1794 is permanently expanded.

FIG. 68 illustrates an embodiment of the coaptation assistance element1700 deployed within the heart mitral valve. In some embodiments, thecoaptation assistance element 1700 is placed over the posterior leaflet14 to create a new surface onto which the native leaflet, here theanterior leaflet 12, can coapt. The zone of coaptation occurs betweenthe anterior leaflet 12 and the coaptation surface 1760 of theleaflet-apposing valve body element 1694. The coaptation assistanceelement 1700 can be anchored to the annulus with the primary anchor 800.In systole and diastole, the leaflet-apposing valve body element 1794 isin an inflated or expanded position.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve of a heart is provided. The coaptationassistance element can include a first surface and an opposed secondsurface. The coaptation assistance element can include a first lateraledge, a second lateral edge, an inferior edge, and a superior edge. Thecoaptation assistance element can include a superior zone and aninferior zone. In some embodiments, the superior zone resides in theplane of an annulus of the heart valve. In some embodiments, theinferior zone extends downward from the superior zone. In someembodiments, the inferior zone comprises a leaflet such that a distancebetween the leaflet and the inferior edge increase during systole anddecreases during diastole.

In some embodiments, a coaptation assistance element for treatingmal-coaptation of a heart valve of a heart is provided. The coaptationassistance element can include a first surface and an opposed secondsurface. The coaptation assistance element can include a first lateraledge, a second lateral edge, an inferior edge, and a superior edge. Thecoaptation assistance element can include a superior zone and aninferior zone. In some embodiments, the superior zone is configured toreside in the plane of an annulus of the heart valve. In someembodiments, the inferior zone is configured to extend downward from thesuperior zone. In some embodiments, the inferior zone comprises aleaflet such that a thickness increases during systole and decreasesduring diastole.

In some embodiments, the coaptation assistance element comprises aframe. In some embodiments, the leaflet is coupled to the frame. In someembodiments, the frame is nitinol. In some embodiments, the coaptationassistance element comprises one or more layers of lamination. In someembodiments, at least one layer is ePTFE. In some embodiments, thecoaptation assistance element comprises an annular hub. In someembodiments, the coaptation assistance element comprises one or morechords coupling the leaflet to at least one edge. In some embodiments,the leaflet comprises biological tissue. In some embodiments, theleaflet is inflatable. In some embodiments, the leaflet is inflated withhydrogel, collagen, or a polymer. In some embodiments, the leafletconfigured to inflate and deflate with each heartbeat. In someembodiments, the leaflet comprises a balloon.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting a coaptation assist body proximate the mitralvalve” includes “instructing the inserting of a coaptation assist bodyproximate the mitral valve.” The ranges disclosed herein also encompassany and all overlap, sub-ranges, and combinations thereof. Language suchas “up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers, and also represent an amount close to the stated amountthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

What is claimed is:
 1. A coaptation assistance element for treatingmal-coaptation of a heart valve of a heart, the coaptation assistanceelement comprising: a first surface and an opposed second surface; afirst lateral edge, a second lateral edge, an inferior edge, and asuperior edge; and a superior zone and an inferior zone, the superiorzone configured to reside within a heart superior to an annulus of theheart valve, the inferior zone extending downward from the superiorzone, wherein the inferior zone comprises a leaflet-apposing valve bodyelement and a leaflet surface, wherein one or more chords extend betweenthe leaflet-apposing valve body element and the leaflet surface.
 2. Thecoaptation assistance element of claim 1, wherein the one or more chordsare configured to stabilize the leaflet-apposing valve body element. 3.The coaptation assistance element of claim 1, wherein the one or morechords are configured to prevent or limit the leaflet-apposing valvebody element from prolapsing.
 4. The coaptation assistance element ofclaim 1, wherein the one or more chords extend between inferior edges ofthe leaflet-apposing valve body element and the leaflet section.
 5. Thecoaptation assistance element of claim 1, wherein the one or more chordsextend between one or more lateral edges of the leaflet-apposing valvebody element and the leaflet section.
 6. The coaptation assistanceelement of claim 1, wherein the coaptation assistance element comprisesat least two chords.
 7. The coaptation assistance element of claim 1,wherein the coaptation assistance element comprises at least threechords.
 8. The coaptation assistance element of claim 1, wherein thecoaptation assistance element comprises at least four chords.
 9. Thecoaptation assistance element of claim 1, wherein the leaflet-apposingvalve body element is configured to expand and contract with eachheartbeat.
 10. A coaptation assistance element for treatingmal-coaptation of a heart valve of a heart, the coaptation assistanceelement comprising: a first surface and an opposed second surface; afirst lateral edge, a second lateral edge, an inferior edge, and asuperior edge; and a superior zone and an inferior zone, the superiorzone configured to reside within a heart superior to an annulus of theheart valve, the inferior zone extending downward from the superiorzone, wherein the inferior zone comprises a leaflet-apposing valve bodyelement and a leaflet surface, wherein the leaflet-apposing valve bodyelement comprises at least one fixed end and at least one free end. 11.The coaptation assistance element of claim 10, wherein theleaflet-apposing valve body element is fixed near an annular hub. 12.The coaptation assistance element of claim 10, wherein theleaflet-apposing valve body element is free for at least limitedmovement relative to the opposed second surface near the inferior edge.13. The coaptation assistance element of claim 10, wherein theleaflet-apposing valve body element comprises one or more chords. 14.The coaptation assistance element of claim 10, wherein theleaflet-apposing valve body element is configured to move outward apre-determined distance based on the length of one or more chords. 15.The coaptation assistance element of claim 10, wherein one or morechords are configured to stabilize the leaflet-apposing valve bodyelement during motion.
 16. The coaptation assistance element of claim10, wherein the leaflet-apposing valve body element is configured tomove away the opposed second surface of the coaptation assistanceelement during systole and configured to move toward the opposed secondsurface during diastole.
 17. A coaptation assistance element fortreating mal-coaptation of a heart valve of a heart, the coaptationassistance element comprising: a first surface and an opposed secondsurface; a first lateral edge, a second lateral edge, an inferior edge,and a superior edge; and a superior zone and an inferior zone, thesuperior zone configured to reside within a heart superior to an annulusof the heart valve, the inferior zone extending downward from thesuperior zone, wherein the inferior zone comprises a leaflet-apposingvalve body element, wherein the leaflet-apposing valve body element isretained by one or more chords during systole.
 18. The coaptationassistance element of claim 17, wherein the leaflet-apposing valve bodyelement is configured to expand in systole.
 19. The coaptationassistance element of claim 17, wherein wherein the leaflet-apposingvalve body element is configured to contract in diastole.
 20. Thecoaptation assistance element of claim 17, wherein the leaflet-apposingvalve body element is configured to mimic the cardiac cycle by movementof the leaflet-apposing valve body element.